Patent Abstract:
A device for supporting a diagnosis of a cancer which provides information useful to decide whether or not an anthracycline anticancer drug should be administered to a cancer patient to be examined is disclosed. Concretely, the device is composed to be able to acquire an activity and an expression of two cyclin dependent kinases (CDK) from a malignant tumor of a cancer patient to be examined, and to acquire a CDK parameters from both of two CDKs. Furthermore the device determines sample data comprising predetermined CDK parameter, and display information of determined sample data. According to the above component, user is easily able to know whether or not a cancer of a cancer patient, whose tumor is similar to the tumor of the cancer patient to be examined, has been recurred in spite of an administration of an anthracycline anticancer drug.

Full Description:
RELATED APPLICATIONS 
       [0001]    This application claims priority under 35 U.S.C. §119 to Japanese Patent Application No. JP2007-259254 filed Oct. 2, 2007, the entire content of which is hereby incorporated by reference. 
       BACKGROUND OF THE INVENTION 
     Field of the Invention 
       [0002]    The present invention relates to a device for supporting a diagnosis of a cancer and a device for predicting an effects of anthracycline anticancer drugs. 
         [0003]    Chemotherapy, that is, treatment by anticancer drugs is being conventionally carried out at one of the treatment methods on cancer patients. The treatment by anticancer drugs is an extremely useful treatment method to suppress the progress of cancer and to suppress recurrence of cancer, but also involves risks of side effects. 
         [0004]    With anticancer drugs, it is known that its effectiveness differs by individual patients, and although some patients take the risk of side effects, great number of patients who cannot sufficiently obtain the anticancer effect from the anticancer drugs exist. In order to solve such problem, various proposals have been made for predicting the effectiveness (sensitivity) of the anticancer drugs in a cancer patient and providing a maximum anticancer drug treatment while avoiding the risk of unnecessary side effects. 
         [0005]    In US 2006/0173632, US 2007/0003438, or US 2007/231837, a method of determining sensitivity of the taxane anticancer drugs based on the activity value and the expression level of the cyclin-dependent kinase (CDK) is disclosed. 
         [0006]    It is also known that anticancer drugs have different effects on the living body depending on the type. For instance, the taxane anticancer drug stops the mitotic division of cells by stabilizing the microtubules in the cell in a polymerized state, and induces apoptosis. The main side effects of the taxane anticancer drug are known as peripheral neuritis. The drugs having the effect of inhibiting the topoisomerase include anthracyclinee anticancer drugs. The anthracyclinee anticancer drugs is an anticancer drug having a strong aggressiveness to directly break the DNA, and involves major side effects such as breaking of myocardial cell membrane and congestive failure. Thus, it is particularly important to predict the sensitivity of the anthracyclinee anticancer drugs in the cancer treatment using the anthracyclinee anticancer drugs. 
       BRIEF SUMMARY 
       [0007]    A first aspect of the invention is a device for supporting a diagnosis of a cancer comprising: acquiring means for acquiring a first cyclin dependent kinase (first CDK) parameter which is capable to be acquired from an activity value and an expression level of the first CDK, and a second cyclin dependent kinase (second CDK) parameter which is capable to be acquired from an activity value and an expression level of the second CDK, based on an activity value and an expression level of the first CDK contained in a first malignant tumor of a cancer patient to be examined and on an activity value and an expression level of the second CDK contained in the first malignant tumor; a memory storing a plurality of sample data, each of the sample data comprising: a first CDK parameter acquired from an activity value and an expression level of the first CDK contained in a second malignant tumor of a sample patient, to whom anthracyclinee anticancer drugs have been administered; a second CDK parameter acquired from an activity value and an expression level of the second CDK contained in the second malignant tumor; and information regarding a cancer recurrence of the sample patient; selecting means for selecting one of the sample data stored in the memory whose first CDK parameter and second CDK parameter are in a prescribed range, wherein the range contains the first CDK parameter and the second CDK parameter of the cancer patient to be examined; and display means for displaying the information regarding a cancer recurrence comprised in the selected sample data. 
         [0008]    A second aspect of the invention is A device for supporting a diagnosis of a cancer comprising: display; and controller, including a memory under control of a processor, the memory storing a plurality of sample data, each of the sample data comprising: first cyclin dependent kinase (first CDK) parameter which is capable to be acquired from an activity value and an expression level of the first CDK contained in a first malignant tumor of a sample patient who has been administered anthracyclinee anticancer drugs; second cyclin dependent kinase (second CDK) parameter which is capable to be acquired from an activity value and an expression level of the second CDK contained in the second malignant tumor; and information regarding a cancer recurrence of the sample patient, and instructions enabling the processor to carry out operations, comprising: acquiring a first CDK parameter based on an activity value and an expression level of the first CDK contained in a second malignant tumor of a cancer patient to be examined, and a second CDK parameter based on an activity value and an expression level of the second CDK contained in the second malignant tumor; selecting one of the sample data stored in the memory whose first CDK parameter and second CDK parameter are in a prescribed range, wherein the range contains the first CDK parameter and the second CDK parameter of the cancer patient to be examined; and controlling the display to display the information regarding a recurrence comprised in the selected sample data. 
         [0009]    A third aspect of the invention is a device for predicting an effects of anthracyclinee anticancer drugs comprising: acquiring means for acquiring a first cyclin dependent kinase (first CDK) parameter which is capable to be acquired from an activity value and an expression level of the first CDK, and a second cyclin dependent kinase (second CDK) parameter which is capable to be acquired from an activity value and an expression level of the second CDK, based on an activity value and an expression level of the first CDK contained in a first malignant tumor of a cancer patient to be examined and on an activity value and an expression level of the second CDK contained in the first malignant tumor; a memory storing a plurality of sample data, each of the sample data comprising: a first CDK parameter acquired from an activity value and an expression level of the first CDK contained in a second malignant tumor of a sample patient, who has been administered anthracyclinee anticancer drugs; a second CDK parameter acquired from an activity value and an expression level of the second CDK contained in the second malignant tumor; and information regarding a cancer recurrence of the sample patient; selecting means for selecting one of the sample data stored in the memory whose first CDK parameter and second CDK parameter are in a prescribed range, wherein the range contains the first CDK parameter and the second CDK parameter of the cancer patient to be examined; predicting means for predicting an effects of anthracyclinee anticancer drugs with the cancer patient to be examined based on the information of the selected sample data; and displaying means for displaying the result of the prediction. 
         [0010]    A fourth aspect of the invention is a device for predicting an effects of anthracyclinee anticancer drugs comprising: acquiring means for acquiring a first cyclin dependent kinase (first CDK) parameter which is capable to be acquired from an activity value and an expression level of the first CDK, and a second cyclin dependent kinase (second CDK) parameter which is capable to be acquired from an activity value and an expression level of the second CDK, based on an activity value and an expression level of the first CDK contained in a first malignant tumor of a cancer patient to be examined and on an activity value and an expression level of the second CDK contained in the first malignant tumor; a memory storing a standard value capable to divide a group of cancer patients into unless two groups different in a risk of cancer recurrence based on a first CDK parameter and a second CDK parameter, wherein the patients have not been administered anthracyclinee anticancer drugs; comparing means for comparing the first CDK parameter and the second CDK parameter of the cancer patient to be examined with the standard value stored in the memory; predicting means for predicting an effects of anthracyclinee anticancer drugs with the cancer patient to be examined based on the result of the comparing; and displaying means for displaying the result of prediction. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  is a perspective explanatory view of a first embodiment of a device of the present invention; 
           [0012]      FIG. 2  is a perspective explanatory view of a tip setting member and a solid phase tip for protein in the device shown in  FIG. 1 ; 
           [0013]      FIG. 3  is a cross sectional explanatory view of the tip setting member and the solid phase tip for protein in the device shown in  FIG. 1 ; 
           [0014]      FIG. 4  is an exploded explanatory view of an upper plate and a lower plate of the solid phase tip for protein; 
           [0015]      FIG. 5  is a perspective explanatory view of the solid phase tip for protein with the upper plate attached to the lower plate; 
           [0016]      FIG. 6  is a cross sectional explanatory view of a column of a specimen preparation member of an activity measurement unit in the device shown in  FIG. 1 ; 
           [0017]      FIG. 7  is a perspective view of the specimen preparation member of the activity measurement unit in the device shown in  FIG. 1 ; 
           [0018]      FIG. 8  is a top view of a fluid manifold of the specimen preparation member shown in  FIG. 7 ; 
           [0019]      FIG. 9  is a cross sectional view taken along line D-D of  FIG. 8 ; 
           [0020]      FIG. 10  is a fluid circuit diagram of the specimen preparation member shown in  FIG. 7 ; 
           [0021]      FIG. 11  is a block diagram showing a partial configuration of the device (control system for controlling the device) of the present invention; 
           [0022]      FIG. 12  is a block diagram showing a hardware configuration of a data processing unit; 
           [0023]      FIG. 13  is a block diagram showing a hardware configuration of a body controller; 
           [0024]      FIG. 14  is a view schematically describing a cell cycle; 
           [0025]      FIG. 15  is a view showing an overall flow of one example of a process by the device; 
           [0026]      FIG. 16  is a view showing an overall flow of one example of a process by the device; 
           [0027]      FIG. 17  is a view showing a flow of one example of a preparation process of the expression level measurement specimen; 
           [0028]      FIG. 18  is a view showing a flow of one example of a preparation process of the activity measurement specimen; 
           [0029]      FIG. 19  is a view showing an overall flow of one example of an analyzing process by the device; 
           [0030]      FIG. 20  is a view showing an example of a display screen; 
           [0031]      FIG. 21  is a schematic explanatory view of a graph shown on a distribution diagram display region in the display screen of a diagnosis support device of a second embodiment; 
           [0032]      FIG. 22  is a schematic explanatory view of a graph shown on a distribution diagram display region in the display screen of a diagnosis support device of a third embodiment; 
           [0033]      FIG. 23  is a schematic explanatory view of a graph shown on a distribution diagram display region in the display screen of a diagnosis support device of a fourth embodiment; 
           [0034]      FIG. 24  is a graph showing cancer patients not treated with anticancer drug in three groups of different recurrence risks; 
           [0035]      FIG. 25  is a view showing an example of the display screen; 
           [0036]      FIG. 26  is an explanatory view showing the usage procedures of the sample and the like in the device; and 
           [0037]      FIG. 27  is a view showing an example of the display screen. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0038]    A device for supporting a diagnosis of a cancer of the present invention, a device for predicting effectiveness of the anthracycline anticancer drugs of the present invention, and a method of predicting the effectiveness of the anthracycline anticancer drugs in a cancer patient to be examined of the present invention will be described in detail below with reference to the accompanying drawings. 
         [0039]    Malignant tumors are tumors that invade or metastasize to other tissues, and enlarge at various sites of the body thereby threatening the life. The malignant tumor includes cancer or malignant tumor originating from epithelial tissue, and sarcoma or malignant tumor originating from non-epithelial tissue. Specifically, the malignant tumor includes malignant tumors forming at positions such as breast, lung, liver, stomach, large intestine, pancreas, uterus, testis, ovaria, thyroid, accessory thyroid, lymphography, and the like. The malignant tumor can be obtained from cancer patients having breast cancer, lung cancer, liver cancer, gastric cancer, large intestine cancer, pancreas cancer, prostate cancer, and the like. 
         [0040]    [1] CDK Serving as Parameter in Cancer 
         [0041]    The cyclin-dependent kinase (CDK) accurately reflects and represents the state of malignant tumor in a patient with cancer. The CDK shows similar profile for cancer patients having malignant tumors of a similar state. Thus, the likeliness of the cancer to recur, the effectiveness of the anticancer drug, and the like can be evaluated based on a first parameter acquired from an activity value and an expression level of a first CDK in the malignant tumor and a second parameter acquired from an activity value and an expression level of a second CDK in the malignant tumor. 
         [0042]    The recurrence refers to a case where the same malignant tumor reappears in the remaining organs after an organ is partially removed to extirpate the malignant tumor, and a case where the tumor cell is separated from a primary tumor and conveyed to a remote tissue (remote organ), and independently grows thereat (metastasize and recur). Generally, “likely to recur” refers to a case where there is a possibility the cancer will recur within five years after the extirpative surgery. Since the death rate of the patients recognized with recurrence within five years is high, predicting the recurrence within five years after the extirpative surgery has clinical meaning. In stage classification, stage III has a recurrence rate of 50%, and recurrence is likely to occur compared to stage II (recurrence rate of 20%). 
         [0043]    In the present specification, the cyclin-dependent kinase is a collective term of a phosphorylated enzyme group activated by being bounded to cyclin. The cyclin-dependent kinase functions in a specific time of the cell cycle depending on the type thereof. In the present specification, the CDK inhibitor is a collective term of a factor group that bonds with the cyclin CDK complex and inhibits the activity of the cyclin CDK complex. 
         [0044]    The cell cycle is a cycle that the cell starts to grow and return to the starting point as two daughter cells after events of DNA replication, distribution of chromosomes, nuclear division, cytoplasmic division, and the like. The cell cycle is divided into four periods of G 1  period, S period, G 2  period, and M period, as shown in  FIG. 14 . The S period is the replication period of DNA, and the M period is the division period. The G 1  period is a preparation period for the cell to enter the S period between the completion of mitotic division and the start of DNA synthesis. After passing a critical point (point R in animal cell) in the G 1  period, the cell cycle starts, and normally completes one cycle without stopping in the middle. The G 2  period is a preparation period for the cell to enter the M period between the termination of DNA synthesis and the start of mitotic division. Main check points of the cell cycle is immediately before entering the S period from the G 1  period (G 1  check point), and the transition period (G 2 /M check point) from the G 2  period to mitotic division. In particular, the G 1  check point is important as it triggers the start of the S period. This is because, after passing a certain point of the G 1  period, the cell advances the cell cycle as S period □ G 2  period □ M period □ G 1  period without stopping the growth even if a growth signal is not provided. The cell that has stopped growing enters a rest period (G 0 ) having DNA content of the G 1  period, and the state deviates from the cell cycle. Due to growth induction, the cell can advance to the S period after a time slightly longer than the G 1  period in the cell cycle. 
         [0045]    The CDK is not particularly limited, and may be CDK1, CDK2, CDK4, CDK6, and the like. The CDK also includes CDK belonging to cyclin A-dependent kinase, CDK belonging to cyclin B-dependent kinase, CDK belonging to cyclin D-dependent kinase, CDK belonging to cyclin E-dependent kinase, and the like. The cyclin A-dependent kinase is not particularly limited as long as it is CDK that indicates activity by being bound to cyclin A, but includes CDK1, CDK2, and the like. The cyclin B-dependent kinase is not particularly limited as long as it is CDK that indicates activity by being bound to cyclin B, but includes CDK1 and the like. The cyclin D-dependent kinase is not particularly limited as long as it is CDK that indicates activity by being bound to cyclin D, but includes CDK4, CDK6, and the like. The cyclin E-dependent kinase is not particularly limited as long as it is CDK that indicates activity by being bound to cyclin E, but includes CDK2 and the like. 
         [0046]    Such CDK activates a predetermined period of the cell cycle as shown in table 1 by being a cyclin-CDK complex (hereinafter also referred to as “active CDK”) bound to the corresponding cyclin, as shown in table 1. For instance, CDK1 becomes active by binding to cyclin A or B, CDK2 becomes active by binding to cyclin A or E, and CDK4 and CDK6 become active by binding to cyclin D1, cyclin D2, or cyclin D3. The CDK activity sometimes has the activity inhibited by the CDK inhibitor as shown in table 1. For instance, p21 inhibits CDK1 and CDK2, p27 inhibits CDK2, CDK4, and CDK6, and p16 inhibits CDK4 and CDK6. 
         [0000]    
       
         
               
               
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                   
                   
                 Binding 
                   
               
               
                   
                 Binding 
                 CDK 
               
               
                 CDK 
                 cyclin 
                 inhibitor 
                 Operating period of active CDK 
               
               
                   
               
             
             
               
                 CDK4 
                 Cyclin D1 
                 p27, p16 
                 G 1  period 
               
               
                 CDK6 
                 Cyclin D2 
               
               
                   
                 Cyclin D3 
               
               
                 CDK2 
                 Cyclin E 
                 p27 
                 G 1  period → S period transition 
               
               
                 CDK2 
                 Cyclin A 
                 p21, p27 
                 S period active 
               
               
                 CDK1 
                 Cyclin A 
                 p21 
                 G 2  period → M period transition 
               
               
                   
                 Cyclin B 
               
               
                 Cyclin A- 
                 Cyclin A 
                 p21, p27 
                 CDK1: G 2  period → M period 
               
               
                 dependent 
                   
                   
                 CDK2: middle period of S period 
               
               
                 kinase 
               
               
                 Cyclin B- 
                 Cyclin B 
                 p21 
                 CDK1: G 2  period → M period 
               
               
                 dependent 
               
               
                 kinase 
               
               
                 Cyclin D- 
                 Cyclin D 
                 p27, p16 
                 CDK4, CDK6: G 1  period 
               
               
                 dependent 
               
               
                 kinase 
               
               
                   
               
             
          
         
       
     
         [0047]    Among the CDKs, the activity value and the expression level of the first CDK are measured and the first parameter is acquired from the activity value and the expression level, and the activity value and the expression level of the second CDK are measured and the second parameter is acquired from the activity value and the expression level. The first parameter is a ratio of the expression level and the activity value of the first CDK, specifically, the specific activity represented with the following equation (I): 
         [0000]      Specific activity of first CDK=activity value of first CDK/expression level of first CDK  (I) 
         [0048]    The second parameter is a ratio of the expression level and the activity value of the second CDK, specifically, the CDK specific activity represented with the following equation (II): 
         [0000]      Specific activity of second CDK=activity value of second CDK/expression level of second CDK  (II) 
         [0049]    The CDK activity value refers to the level (unit is expressed as U (unit)) of the kinase activity calculated from the amount of substrate that binds with a specific cyclin, and phosphorylates the cyclin. The substrate to which the CDK phosphorylates includes histon H 1  for active CDK1 and active CDK2, and Rb (retinoblastoma protein) for active CDK4 and active CDK6). The CDK activity value can be measured with a conventional CDK activity measurement method. Specifically, there may be a method of preparing a specimen containing the active CDK from the cell dissolved solution of the measurement specimen, retrieving  32 P into the substrate protein by using the relevant specimen and the  32 P labeled ATP (γ-[ 32 P]-ATP), measuring the labeled quantity of the  32 P labeled phosphorylated substrate, and determining the quantity based on the standard curve created with a standard product. A method that does not use label of the radioactive substance includes a method disclosed in Japanese Laid-Open Patent Publication No. 2002-335997. This method is a method of preparing a specimen containing the target active CDK from the cell solubilizing solution of the measurement specimen, reacting adenosine 5′-O-(3-thiotriphosphate) (ATP-γS) and the substrate protein, introducing monothiophosphate group to serine residue or threonine residue of the substrate protein, bonding fluorescent labeled substance or labeled enzyme to the sulfur atom of the introduced monothiophosphate group to label the substrate protein, measuring the labeled quantity (fluorescence quantity when fluorescent labeled substance is used) based on the labeled thiophosphate group, and determining the quantity based on the standard curve created with the standard product. 
         [0050]    The specimen provided for activity measurement is prepared by specifically obtaining the target CDK from the solubilizing solution of the tissue containing the malignant tumor to be measured. In this case, the specimen may be prepared using an anti-CDK antibody specific to the target CDK. The specimen may be prepared using an anti-cyclin antibody in the case of activity measurement of a specific cyclin-dependent kinase (e.g., cyclin A-dependent kinase, cyclin B-dependent kinase, cyclin E-dependent kinase). In either case, the specimen contains CDK other than the active CDK. For instance, the specimen contains a complex in which the CKD inhibitor is bound to the cyclin CDK complex. When the anti-CDK antibody is used, the specimen contains CDK single body, complex of CDK and cyclin and/or CDK inhibitor, complex of CDK and other compound, and the like. Therefore, the activity value is measured as a unit (U) calculated from the amount of phosphorylated substrate under a state that active type, inactive type, and various competitive reactions coexist. 
         [0051]    The CDK expression level is the target CDK level (unit corresponding to number of molecules) measured from the cell solubilizing solution, and is measured with a conventionally known method of measuring the target protein quantity from the protein mixture. For instance, ELISA method, western blot method, and the like may be used, or measurement may be carried out with a method disclosed in Japanese Laid-Open Patent Publication No. 2003-130871. The target protein (CDK) is captured using a specific antibody. For instance, all the CDK1 existing within the cell (including CDK single body, complex of CDK and cyclin and/or CDK inhibitor, complex of CDK and other compound) can be captured using the anti-CDK1 antibody. 
         [0052]    Therefore, the specific activity calculated from the equations (I) and (II) corresponds to the proportion of the CDK indicating activity of the CDK existing in the cell, and is the CDK activity level based on the growth state of the malignant tumor cell, which is the target of determination. The CDK specific activity thus obtained does not depend on the measurement specimen preparation method. In particular, the measurement specimen (cell solubilizing solution) prepared from the biopsy material is likely to be influenced by the size of non-cellular tissues such as extracellular matrix contained in the actually collected tissue. Therefore, there is a large meaning to use the specific activity in which such influence is eliminated, and the correlation with the clinical characteristics is high compared to the simple activity value. 
         [0053]    Which CDK activity is superior can be known from the specific activity of the first CDK and the specific activity of the second CDK, whereby the extent of the cell proportion in any period of the cell cycle can be known, or the cell proportion of which period is superior can be known. 
         [0054]    The type of CDK for measuring the specific activity is not particularly limited, and may be appropriately selected. Generally, since the cancer cells actively grow deviating from the normal growth control, cell proportion in the S period and the G 2  period is considered to be large, and the cells are considered to become cancerous in such case. The progression of such cancer can be fast, and thus such cancer can be malignant. Furthermore, heteroploidy is considered to occur when an abnormal M period has elapsed or the cell has advanced to the G 1  period without going through the M period and then entered to the S period, and thus, the cell is considered to be malignant when the cell proportion in the M period is small. Therefore, the CDK1 is used as the first CDK and the CDK2 is used as the second CDK, classification to groups is carried out according to the magnitude of the CDK1 specific activity, wherein the CDK2 specific activity value takes a value reflecting the cell ratio in the S period of the groups having a similar CDK1 specific activity. When cells in the S period are in great numbers, the tissue where the cells are configuring cells can be determined as clinically malignant, that is, as a malignant cancer that is likely to metastasize and has poor prognosis. 
         [0055]    Therefore, information useful in diagnosing the cancer patient to be examined can be provided by obtaining the first parameter in the malignant tumor of the cancer patient to be examined, such as the specific activity of the first CDK, and the second parameter or the specific activity of the second CDK, and providing information having the first parameter and the second parameter within a sample data extraction range defined based on the first parameter and the second parameter of the malignant tumor of the cancer patient to be examined and being related to the recurrence of the cancer patient administered with the anthracycline anticancer drug. 
         [0056]    Information useful in predicting the effectiveness of the anthracycline anticancer drugs in the cancer patient to be examined, in selecting the treatment method for the cancer patient to be examined, and the like can be provided by obtaining the first parameter in the malignant tumor of the cancer patient to be examined, such as the specific activity of the first CDK, and the second parameter or the specific activity of the second CDK, and providing information having the first parameter and the second parameter within a sample data extraction range defined based on the first parameter and the second parameter of the malignant tumor of the cancer patient to be examined and being related to the recurrence, after the malignant tumor is extirpated, of the cancer patient administered with the anthracycline anticancer drug. 
         [0057]    [2] Diagnosis Support Device 
         [0058]    The diagnosis support device according to one embodiment (first embodiment) of the present invention will be described below. The diagnosis support device according to the present embodiment uses the specific activity of the first CDL as the first parameter and the specific activity of the second CDK as the second parameter. 
         [0059]    Specifically, the diagnosis support device according to the first embodiment acquires the expression levels and the activity values of the CDK1 and the CDK2 of the malignant tumor collected from the cancer patient to be examined. The CDK1 specific activity and the CKD2 specific activity are calculated from the expression levels and the activity values of the acquired CDK1 and CDK2. A sample data extraction range is determined based on the calculated CDK1 specific activity and CDK2 specific activity. The device of the first embodiment stores data including sample data in which the first parameter and the second parameter of the malignant tumor collected from the cancer patient administered with the anthracycline anticancer drugs are corresponded to information related to the recurrence of the cancer patient after the malignant tumor is extirpated. The sample data of the patient is extracted from the data stored in advance. Screen information for displaying a screen including the information related to the recurrence contained in the extracted sample data and the information on the cancer patient to be examined on a display device is generated, and the generated screen is allowed to display. 
         [0060]    The data stored in advance in the device of the first embodiment contains the sample data. The sample data includes information obtained from a plurality of cancer patients administered with the anthracycline anticancer drugs. Specifically, the first parameter and the second parameter of the malignant tumor collected from the cancer patient are included. Furthermore, information related to the recurrence of the cancer patient after the malignant tumor is extirpated is also included. The information related to the recurrence after the malignant tumor is extirpated specifically includes presence of recurrence of the cancer patient, a number of days from extirpation of the malignant tumor to recurrence (if recurrence has not occurred, a number of days elapsed from the extirpation). 
         [0061]    The screen displayed by the display device on the device of the first embodiment includes information related to recurrence contained in the extracted sample data and the information on the cancer patient to be examined. The information related to the recurrence contained in the extracted sample data specifically includes information on the presence of recurrence of the relevant patient. Furthermore, the recurrence rate calculated based on the information on the presence of the recurrence is also included therein. The information on the cancer patient to be examined includes ID number, age, and the like of the cancer patient to be examined. Furthermore, the CDK1 specific activity and the CDK2 specific activity of the malignant tumor of the cancer patient to be examined are also included therein. 
         [0062]      FIG. 1  is a perspective explanatory view of the first embodiment of the device of the present invention. The diagnosis support device according to the first embodiment is configured by a measuring device A and a solubilizing device B. The measuring device A is configured by a measurement unit  501  and a data processing unit  12 . The measuring unit  501  measures the activity value and the expression level of the CDK1 and the activity value and the expression level of the CDK2, and is mainly configured by a detecting member  4  arranged at the front portion of a device body  20 ; a tip setting member  1 ; first reagent setting member  5  and second reagent setting member  6 ; an activity measurement unit  2  arranged at a back portion of the device body  20 ; a waste bath  7  for accommodating waste liquid and a pipette washing bath  8  for washing pipette; a dispensing mechanism member  3  arranged on the upper side of the device body  20 , for moving the pipette in three directions (X direction, Y direction, and Z direction); and a fluid member  9  and a body controller  10  arranged at the back part of the device body  20 . The data processing unit  12  is communicably connected to the body controller  10 . A pure water tank  13 , a washing liquid tank  14 , a waste liquid tank  15 , and a pneumatic source  11  are arranged in the measuring device A. The pure water tank  13  stores pure water for washing a flow channel at the end of measurement and is connected to the fluid member  9  with a conduit  21 ; the washing liquid tank  14  stores washing liquid for washing the pipette and is connected to the pipette washing bath  8  with a conduit  22 ; and the waste liquid tank  15  for accommodating the waste liquid is connected to the waste bath  7  with a conduit  23 . The solubilizing device B for obtaining a sample that can be processed in the measuring device A from a biological specimen is arranged next to the measuring A in the diagnosis support device according to the first embodiment. 
         [0063]    The solubilizing device B and the measuring device A will be described in order below. 
       [Solubilizing Device] 
       [0064]    The solubilizing device B prepares a liquid sample that can be processed in the measuring device A from the biological specimen of the tissue and the like extirpated from the patient prior to the process by the measuring device A, and is mainly configured by a housing  30 , an operating member  31  arranged on the upper side at the front surface of the housing  30 , a driving member  32  including a pair of pestles  34  for pressing and grinding the biological specimen, and a sample setting member  33  to be set with an eppen tube  35  accommodating the biological specimen. 
         [0065]    The driving member  32  moves the pestles  34  in the up and down direction and provides rotational movement thereto, so that the biological specimen injected into the eppen tube  35  is pressed and grinded. A controller (not shown) for controlling the operation of the driving member  32  is arranged in the housing  30 . 
         [0066]    An operation button  31   a , an operation lamp  31   b , and a display part  31   c  for displaying the state of the device and error message are arranged on the operating member  31 . A cooling means (not shown) is arranged in the sample setting member  33  to maintain the biological specimen in the eppen tube (product name) set in a concave area of the upper surface of the sample setting member  33  at a constant temperature. 
         [0067]    The supernatant solution of the biological specimen solubilized by the solubilizing device B and subjected to centrifugal process by a centrifugal machine (not shown) is collected to a predetermined sample container and set in the first reagent setting member  5  of the measuring device A. 
       [First Reagent Setting Member] 
       [0068]    A cooling means (not shown) is arranged in the first reagent setting member  5 , similar to the sample setting member  33 , to maintain the sample, the CDK1 antigen (calibration 1), the CDK2 antigen (calibration 2), the fluorescent labeled CDK1 antibody, the fluorescent labeled CDK2 antibody and the like in the container such as screw cap set in the concave area of the upper surface of the first reagent setting member  5  at a constant temperature. In the first embodiment, a total of 20 concave areas are formed in a matrix of five by four, so that a maximum of 20 containers such as screw cap can be set. 
       [Second Reagent Setting Member] 
       [0069]    The second reagent setting member  6  is arranged next to the first reagent setting member  5 . A plurality of concave areas is formed in the second reagent setting member  6 , similar to the first reagent setting member  5 , and the eppen tube (product name) and the containers such as screw cap with buffer, substrate solution, and fluorescent enhancement reagent are set in these concave areas. 
         [0070]    Prior to the process by the measuring device A, a solid phase tip for protein is set in the tip setting member  1 , and a column is set in the activity measurement unit  2 . 
       [Tip Setting Member] 
       [0071]    The tip setting member  1  is made up of aluminum blocks, wherein a concave part  102  for mounting the solid phase tip for protein  101  is formed at the upper surface and three aspiration ports  103  are formed at the bottom part, as shown in  FIGS. 2 and 3 . More specifically, the tip setting member  1  includes a first concave part  102  of rectangular shape at the upper surface, and three second concave parts  104  also of rectangular shape at the bottom part of the first concave part  102 . The second concave parts  104  are independent from each other by a partition wall  105  so as to be in a non-communicating state when the solid phase tip for protein  101  is mounted on the tip setting member  1 . A rubber elastic gasket  106  of rectangular frame shape is arranged at the peripheral edge of the second concave part  104  at the bottom surface of the first concave part  102 . 
         [0072]    The second concave part  104  includes a cross-shaped groove  107  at the bottom part and the aspiration port  103  at the center of the bottom part, wherein the groove bottom of the groove  107  is inclined so as to become deeper towards the center from the peripheral edge of the second concave part  104 . The aspiration port  103  communicates with a nipple  108  arranged to connect to an external aspiration pneumatic source  11 . A tube  109  having one end connected to the aspiration pneumatic source  11  side has the other end connected to the nipple  108 . An open/close valve  110  is arranged in the tube  109 . 
         [0073]    The solid phase tip for protein  101  to be hereinafter described in detail is mounted horizontally at the bottom surface of the first concave part  102  by way of a gasket  106 . The aspiration pump is activated after the protein containing specimen solution is injected or dropped into each well of the solid phase tip for protein  101 . 
         [0074]    The solid phase tip for protein  101  is then air tightly attracted to the bottom surface of the first concave part  102  by way of the gasket  106 , and the specimen solution in each well is aspirated through the porous film, to be hereinafter described, whereby the protein to be measured is solid phase formed on the porous film. In  FIGS. 2 and 3 ,  130  is a pressing mechanism for pressing and fixing the solid phase tip for protein  101  to the bottom surface of the first concave part  102 . The pressing mechanism  130  is sled in a direction of the arrow in the figure after the solid phase tip for protein  101  is mounted on the first concave part  102 , so that the upper part thereof presses the upper surface of the solid phase tip for protein  101  and fixes the same to the first concave part  102 . 
         [0075]    As shown in  FIGS. 4 and 5 , the solid phase tip for protein  101  is configured by a porous film  111  and a filter paper  112 , and upper plate  113  and lower plate  114  for sandwiching the porous film  111  and the filter paper  112 . The solid phase tip for protein  101  has a function of contacting the antibody solution containing antibody of cyclin-dependent kinase and the biological specimen (sample). 
         [0076]    As shown in  FIGS. 4 and 5 , the upper plate  113  is configured by three plates being independent from each other, that is, a first upper plate  113   a , a second upper plate  113   b , and a third upper plate  113   c . Each upper plate has a rectangular plate shape, wherein the first upper plate  113   a  and the second upper plate  113   b  are both formed with twelve oval through holes  115  arrayed in a matrix form of four by three, and the third upper plate  113   c  is formed with sixteen oval through holes  115  arrayed in a matrix form of four by four. Each upper plate includes a region, which is independent from each other for specimen processing, formed with a plurality of through holes. A groove  116  is formed along a short side at the bottom surface of each upper plate. 
         [0077]    A total of forty oval through holes  117  arrayed in a matrix form is formed in the lower plate  114  having a rectangular plate shape at positions corresponding to each through hole  115  of the upper plates  113   a ,  113   b ,  113   c . The through holes  117  have the same shape and cross sectional area as the through holes  115 . The lower plate  114  has a region formed with a plurality of through holes corresponding to each region of the upper plates  113   a ,  113   b ,  113   c.    
         [0078]    A rib-shaped convex part  118  that goes around the periphery of the forty through holes  117  once, and a partition wall  119  for partitioning the through holes  117  to three regions in correspondence to each region of the upper plate  113   a ,  113   b ,  113   c  are formed on the upper surface of the lower plate  114 . Three rectangular porous film installing regions are partitioned on the inner side by the convex part  118  and the partition wall  119 . The upper plate  113  and the lower plate  114  may be made of vinyl chloride resin and the like. 
         [0079]    As shown in  FIGS. 2 to 5 , a stacked body including the porous film  111  and the filter paper (filter)  112  is mounted on the porous film installing region of the lower plate  114 , and the grooves  116  of each upper plate  113   a ,  113   b ,  113   c  are sequentially fitted to the corresponding convex part  118  of the lower plate  114 , so that the upper plates  113   a ,  113   b ,  113   c  are attached to the lower plate  114  thereby forming the solid phase tip for protein  101 . Each through hole  115  and each through hole  117  then become coaxial to each other. 
         [0080]    The solid phase tip for protein described above has the upper plate divided into three regions, so that three regions can be aspirated independently, but the number of upper plates may be two, or four or more, and is not particularly limited in the present invention. The number of upper plates is appropriately selected in view of the number of measurement items and the number of samples. 
       [Activity Measurement Specimen Preparation Unit] 
       [0081]    As shown in  FIGS. 6 to 10 , the activity measurement specimen preparation unit  2  includes a plurality of specimen preparation members  211  each including a column  201  and a fluid manifold  213 , and is used to measure the activity value of the CDK. 
         [0082]    The column  201  shown in  FIG. 6  is made of a cylindrical body made of vinyl chloride resin, and includes therein a carrier holding member  202  for holding a carrier  206  used to isolate the target substance in the liquid specimen, and a liquid storage member  204  for receiving and storing the liquid specimen to introduce the liquid specimen to the carrier holding member  202 . The column  201  has an opening  205  through which the liquid sample can be externally injected or from which the liquid specimen can be collected from the outside at the upper part of the liquid storage member  204 , and includes a connection flow channel  203  for introducing the liquid specimen to the fluid manifold  213  to the lower part of the carrier holding member  202  and receiving the liquid specimen from the fluid manifold  213 . The column  201  configures a means for contacting the substrate solution containing a predetermined substrate and the biological specimen (sample). 
         [0083]    The carrier  206  is made of monolithic silica gel of circular cylinder shape, wherein the monolithic silica gel has a configuration in which the three-dimensional network frame work and the clearance thereof are integrated, unlike to the particle carrier. The predetermined CDK antibody is immobilized to the monolithic silica gel. The carrier  206  is inserted to the carrier holding member  202  from the lower opening of the column  201 , and is elastically pushed and supported by a fixing pipe  208  by way of an O-ring  207 . The fixing pipe  208  is press-fit from the lower opening of the column  201 , wherein the fixing pipe  208  and the hole of the O-ring  207  form the connection flow channel  203 . 
         [0084]    A mounting flange  209  for mounting and fixing the column  201  to the specimen preparation member  211  is formed at the lower end of the column  201 . The flange  209  is an oval flange formed by cutting out both sides of a disc shaped flange having a diameter D in parallel so as to have a width W (W&lt;D). 
         [0085]      FIG. 7  is a perspective explanatory view of the specimen preparation member of the activity measurement unit in the device of  FIG. 1 . As shown in  FIG. 7 , the specimen preparation member  211  includes an L-shaped supporting plate  212 , and the fluid manifold  213 , a syringe pump  214 , and a stepping motor with reducer  215  are fixed on the supporting plate  212 . 
         [0086]    A screw shaft  216  is connected to the output shaft of the stepping motor  215 . A drive arm  217  to be screwed to the screw shaft  216  is connected to the distal end of a piston  218  of the syringe pump  214 . The piston  218  moves up and down when the screw shaft  216  is rotated by the stepping motor  215 . The syringe pump  214  and the fluid manifold  213  are connected to a liquid feeding tube  250  by way of connectors  219 ,  220 . The syringe pump  214  is connected to a chamber  234  (see  FIG. 10 ) accommodating fluid (washing liquid) for filling the flow channel by a liquid feeding tube  220   b  by way of a connector  220   a.    
         [0087]    As shown in  FIGS. 8 and 9 , the fluid manifold  213  includes a column connecting part  221  to which the lower opening of the column  201  is connected. 
         [0088]    The fluid manifold  213  includes a flow channel  223  therein, and has an electromagnetic valve  225  for opening/closing the flow channel  223  and the column connecting part  221  on the lower surface. The fluid manifold  213  has a connector connection screw hole  226  for connecting a connector  220  on the side surface, which screw hole  226  is connected to the flow channel  223 . 
         [0089]      FIG. 10  is a fluid circuit diagram of the specimen preparation member shown in  FIG. 7 .  FIG. 10  shows a state in which the syringe pump  214  is connected to the fluid manifold  213  by way of the connector  220 . A chamber  234  is connected to the syringe pump  214  by way of the electromagnetic valve  233 , and positive pressure is applied to the chamber  234  from a positive pressure source  235 . 
         [0090]    A method of mounting the column  201  to the fluid manifold  213  will be now described. 
         [0091]    As shown in  FIGS. 8 to 10 , a column mounting concave part  227  for receiving the lower end of the column  201  is formed on the upper surface of the fluid manifold  213 , the center of the bottom part of the concave part  227  passes through the column connecting part  221 , and an O-ring  228  is attached to the circumference of the bottom part. Two pressing plates  229 ,  230  having a cross section of L-shape are fixed in parallel on the upper surface of the fluid manifold  213  at an interval wider than the width W and narrower than D with the column mounting concave part  227  as the center. 
         [0092]    In order to prevent sample or reagent that has passed the carrier  206  inside the column  201  fixed to the fluid manifold  213  from contacting fluid (washing liquid) that fills the flow channel  223  inside the fluid manifold  213  and being diluted, the electromagnetic valve  225  is opened (electromagnetic valve  233  is closed) before the column  201  is fixed to the column mounting concave part  227  and the syringe pump  214  is aspiration operated only by about 16 μL. The liquid level of the column connecting part  221  thereby lowers and an air gap forms. 
         [0093]    Subsequently, the column  201  is mounted to column mounting concave part  227  so that the flange  209  passes between the pressing plates  229 ,  230 , and then rotated clockwise or counterclockwise by 90 degrees. The portion of the diameter D of the flange  209  engages the pressing plates  229 ,  230 , and the flange  209  is fixed by the pressing plates  229 ,  230  due to the elasticity of the O-ring  228 . When removing the column  201 , the column  201  is rotated either to the left or the right by 90 degrees while being pushed. 
         [0094]    When the column  201  is mounted to fluid manifold  213  of the specimen preparation unit  211 , the concave part  227  of the fluid manifold  213  is filled with manually or automatically dispensed fluid in order to prevent air bubbles from mixing, but the fluid flows out from increase in volume when the distal end of the column  201  is inserted to the concave part  227 . An overflow liquid storage concave part  231  is arranged at the periphery of the column mounting concave part  227  in order to prevent the fluid from flowing out to the periphery, and an overflow liquid discharging concave part  232  for aspirating and discharging the overflow liquid by pipette is arranged at one part of the overflow liquid storage concave part  231 . 
         [0095]    Various samples and reagents are injected or aspirated to or from a predetermined location by the dispensing mechanism member  3  equipped with the pipette. 
         [0096]    The operation of the upper opening  205  of the column  201  in a case where the sample or the reagent is injected will be now described. The electromagnetic valve  225  is first opened (electromagnetic valve  233  is closed), and the syringe pump performs the aspirating operation when the sample or the reagent is injected to the opening  205 . The air gap and the sample or the reagent are then passed through the electromagnetic valve  225 , and then aspirated to the syringe pump side. The syringe pump then performs ejecting operation. The sample or the reagent is then passed through the electromagnetic valve  225 , and sent to the column  201 . 
       [Dispensing Mechanism Member] 
       [0097]    As shown in  FIG. 1 , the dispensing mechanism member  3  includes a frame  352  for moving the pipette in the X direction, a frame  353  for moving the pipette in the Y direction, and a plate  354  for moving the pipette in the Z direction. 
         [0098]    The frame  352  includes a screw shaft  355  for moving the plate  354  in the direction of the arrow X, a guide bar  356  for supporting and slidably moving the plate  354 , and a stepping motor  357  for rotating the screw shaft  355 . 
         [0099]    The frame  353  includes a screw shaft  358  for moving the plate  352  in the direction of the arrow Y, a guide bar  359  for supporting and slidably moving the frame  352 , and a stepping motor  361  for rotating the screw shaft  358 . 
         [0100]    The plate  354  includes a screw shaft  367  for moving an arm  368  supporting the pipette  362  in the direction of the arrow Z, a guide bar for supporting and slidably moving the arm  368 , and a stepping motor  370  for rotating the screw shaft  367 . 
         [0101]    In the first embodiment, since the dispensing mechanism member  3  is equipped with a pair of pipettes  362 , reagent and the like can be simultaneously injected to two sample containers and content can be simultaneously aspirated from two sample containers, whereby the measuring process can be efficiently performed. 
       [Fluid Member] 
       [0102]    As shown in  FIG. 1 , a fluid member  9 , connected to the pipette washing bath  8  for washing the pipette  362  and each specimen preparation member  211 , for operating the fluid is arranged at the rear part of the device body  20 . As shown in  FIG. 10 , the fluid member  9  includes an electromagnetic valve  225  of each specimen preparation member  211 , an electromagnetic valve  233  for controlling the fluid when filling the liquid from the washing liquid chamber to the syringe  214 , an electromagnetic valve for controlling fluid when aspirating and ejecting the liquid with the pipette  362 , an electromagnetic valve for controlling the fluid when aspirating the liquid wasted from the pipette  362  in the waste bath  7 , and an electromagnetic valve for controlling the fluid when washing the pipette  362  in the pipette washing bath  8 . 
       [Detecting Member] 
       [0103]    The detecting member  4  is provided to measure the fluorescence quantity based on the bound fluorescent labeled substance reflecting the protein quantity and the fluorescence quantity based on the fluorescent labeled substance reflecting the amount of phosphate group captured at the porous film  111  of the solid phase tip for protein  101 , wherein excitation light is irradiated on the solid phase tip for protein  101 , the generated fluorescence is detected, and the electric signal having a magnitude corresponding to the intensity of the detected fluorescence is output to the body controller  10 . A generally used detecting member configured by light source unit, illumination system, and light receiving system can be appropriately adopted for the detecting member  4 . 
       [Data Processing Unit] 
       [0104]      FIG. 11  is a block diagram showing a partial configuration (control system for controlling the device) of the device of the first embodiment. As shown in  FIG. 1 , the data processing unit  12  or the personal computer includes a control member  77 , an input member  78 , and a display member  79 . 
         [0105]    The control member  77  has a function of transmitting an operation start signal of the device to the body controller  10  to be hereinafter described. When a command to start operation is transmitted from the control member  77 , the body controller  10  outputs a drive signal for driving the stepping motor  215  of each specimen preparation member  211 , a drive signal for adjusting the temperature of the first reagent setting member  5 , a drive signal for driving the stepping motors  357 ,  361 ,  370 , and a drive signal for driving the electromagnetic valve in the fluid member  9 . The control member  77  further has a function for analyzing the detection result obtained in the detecting member  4 . 
         [0106]    The detection result obtained in the detecting member  4  is transmitted to the body controller  10 . The body controller  10  transmits the detection result obtained in the detecting member  4  to the control member  77 . 
         [0107]    The display member  79  is arranged to display result of analysis and the like obtained in the control member  77 . 
         [0108]    The configuration of the personal computer used as the data processing unit  12  will be now described in detail. As shown in  FIG. 12 , the control member  77  is mainly configured by a CPU  91   a , a ROM  91   b , a RAM  91   c , an input/output interface  91   d , an image output interface  91   e , a communication interface  91   f , and a hard disc  91   g . The CPU  91   a , the ROM  91   b , the RAM  91   c , the input/output interface  91   d , the image output interface  91   e , the communication interface  91   f , and the hard disc  91   g  are connected with an electric signal line (bus) so as to communicate electrical signals. 
         [0109]    The CPU  91   a  can execute computer programs stored in the ROM  91   b  and the computer programs loaded in the RAM  91   c . The personal computer can serve as the data processing unit  12  when the CPU  91   a  executes the application program  91   h , as hereinafter described, and executes the operations to be hereinafter described. 
         [0110]    The ROM  91   b  is configured by mask ROM, PROM, EPROM, EEPROM, and the like, and is recorded with computer programs to be executed by the CPU  91   a , data used for the same, and the like. 
         [0111]    The RAM  91   c  is configured by SRAM, DRAM, and the like. The RAM  91   c  is used to read out the computer programs recorded on the ROM  91   b  and the hard disc  91   g . The RAM  91   c  is used as a work region of the CPU  91   a  when executing these computer programs. 
         [0112]    Various computer programs to be executed by the CPU  91   a  such as operating system and application program, as well as data used in executing the computer program are installed in the hard disc  91   g . A predetermined application program  91   h  is also installed in the hard disc  91   g . The predetermined application program is a program for acquiring the expression levels and the activity values of the CDK 1 and the CDK 2 from the malignant tumor of the cancer patient to be examined, calculating the CDK 1 specific activity and the CDK 2 specific activity from the acquired expression levels and the activity values of the CDK 1 and the CDK 2, determining a sample data extraction range based on the calculated CDK 1 specific activity and CDK 2 specific activity, extracting sample data having the CDK 1 specific activity and the CDK 2 specific activity within the determined range and of the cancer patient administered with anthracycline anticancer drug (such cancer patient is hereinafter referred to as “relevant patient”), calculating the recurrence rate based on the information related to recurrence contained in the extracted sample data, generating a screen including the calculated recurrence rate and the information on the cancer patient to be examined based on the presence of recurrence contained in the information related to the recurrence and the information related to the recurrence, and displaying the generated screen on the display member  79 . 
         [0113]    In order to acquire the expression level and the activity value, the hard disc  91   g  includes a first database  91   i  for storing a standard curve or conversion data for converting fluorescence intensity to expression level or activity value. The standard curve may be obtained for every measurement of the expression level or the activity value. The first database  91   i  of the hard disc  91   g  stores data to use in the calculation for determining the sample data extraction range, data of default value of the sample data extraction range, and data of a set value of the sample data extraction range input and used in the past. The first database  91   i  of the hard disc  91   g  also stores information related to recurrence. 
         [0114]    The hard disc  91   g  includes a second database  91   j  for storing sample data in which the measurement value such as the activity value and the expression level of great number of cancer patients and the clinical information such as presence/absence of recurrence, a number of days from the extirpation of the malignant tumor to the recurrence occurred (if recurrence did not occur, a number of days elapsed after extirpation), information related to postsurgical treatment such as administration of anthracycline anticancer drug and hormone treatment, information related to living body and the like of the relevant cancer patient are corresponded to each other. 
         [0115]    Operating system providing graphical user interface environment such as Windows (registered trademark) manufactured and sold by US Microsoft Co. is installed in the hard disc  91   g . In the following description, the application program  91   h  according to the first embodiment is assumed to operate on the operating system. 
         [0116]    The input/output interface  91   d  is configured by serial interface such as USB, IEEE1394, RS-232C; parallel interface such as SCSI, IDE, IEEE1284; analog interface such as D/A converter, A/D converter, and the like. The input member  78  such as keyboard and mouse is connected to the input/output interface  91   d , so that the user can input data to the data processing unit  12  by using the input member  78 . 
         [0117]    The communication interface  91   f  is, for example, Ethernet (registered trademark) interface. The data processing unit  12  transmits and receives data with the body controller  10  by using a predetermined communication protocol by means of the communication interface  91   f.    
         [0118]    The image output interface  91   e  is connected to the display member  79  configured by LCD, CRT, or the like, and is configured to output an image signal corresponding to the image data provided from the CPU  91   a  to the display member  79 . The display member  79  displays the image (screen) according to the input image signal. 
       [Body Controller] 
       [0119]    The body controller  10 , connected to each specimen preparation member  211 , the detecting member  4 , the stepping motors  357 ,  361 ,  370 , the fluid member  9  and the like, for controlling the same is arranged at a back part of the device body  20 . 
         [0120]    As shown in  FIG. 13 , the body controller  10  includes a CPU  301   a , a ROM  301   b , a RAM  301   c , a communication interface  301   d , and a circuit part  301   e.    
         [0121]    The CPU  301   a  can execute computer programs stored in the ROM  301   b  and the computer programs read out in the RAM  301   c.    
         [0122]    The ROM  301   b  stores a computer program to be executed by the CPU  301   a , data used in the execution of the computer program, and the like. 
         [0123]    The RAM  301   c  is used in reading out the computer program stored in the ROM  301   b . The RAM  301   c  is used as a work region of the CPU  301   a  when executing these computer programs. 
         [0124]    The communication interface  301   d  is, for example, Ethernet (registered trademark) interface. The body controller  10  can transmit and receive data with the data processing unit  12  by using a predetermined communication protocol by means of the communication interface  301   d.    
         [0125]    The circuit part  301   e  includes a plurality of drive circuits and a signal processing circuit (not shown). The drive circuit is arranged in correspondence to the specimen preparation member  211 , the first reagent setting member  5 , the detecting member  4 , the stepping motors  357 ,  361 ,  370 , and the fluid member  9 . Each drive circuit generates a control signal (drive signal) for controlling the corresponding unit (specimen preparation member  211  if drive circuit corresponding to the specimen preparation member  211 ) according to the instruction data provided from the CPU  301   a , and transmits the control signal to the unit. The output signal of the sensor arranged in the unit is provided to the drive circuit, wherein the drive circuit converts the output signal to a digital signal and provides the same to the CPU  301   a . The CPU  301   a  generates the instruction data based on the provided output signal of the sensor. 
         [0126]    The signal processing circuit is connected to the detecting member  4 . A detection signal indicating fluorescence intensity is output from the detecting member  4 , and such detection signal is provided to the signal processing circuit. The signal processing circuit executes signal processing such as noise removal process, amplification process, and A/D conversion process on the detection signal. The data on the detection result obtained as a result of the signal processing is provided to the CPU  301   a.    
         [0127]    [3] Diagnosis Support of Cancer 
         [0128]    The operation of the diagnosis support system according to the first embodiment will be described. 
       (1) Pre-Process by Solubilizing Device B 
       [0129]    Prior to the process by the measuring device A, liquid sample is collected from the tissue containing the malignant tumor extirpated from a cancer patient by using the solubilizing device B. In the procedure thereof, the tissue is first placed in the eppen tube (product name) with a pin set. The eppen tube (product name) is then set in the sample setting member  33  of the solubilizing device B shown in  FIG. 1 , and the start button of the operating member  31  is pushed, whereby the pestle  34  lowers to a predetermined position and pushes the tissue in the eppen tube (product name) against the bottom of the eppen tube (product name). 
         [0130]    Solubilizing liquid such as buffer solution containing surfactant and proteolysis enzyme inhibitor agent and the like is automatically or manually injected into the eppen tube (product name) in such state. Thereafter, the tissue is grinded by the rotation of the pestle  34 . The drive of the pestle  34  is stopped after a predetermined time has elapsed, the pestle  34  is moved upward, and thereafter, the eppen tube (product name) is taken out from the sample setting member  33 . The solubilized content in the eppen tube (product name) is then set in the centrifugal machine, and the obtained supernatant solution is manually collected as a sample. 
       (2) Setting of Sample and the Like to the Measuring Device A 
       [0131]    The supernatant solution is placed in two sample containers and diluted at dilution ratio different from each other, and thereafter, the sample containers are set at predetermined positions in the first reagent setting member  5 . Of the two samples, one is the sample for expression level measurement, and the other is the sample for activity value measurement. 
         [0132]    The solid phase tip for protein  101  is set in the tip setting member  1 , and eight columns  201  are respectively set in the specimen preparation member  211  of the activity measurement unit  2 . 
       (3) Overall Flow of Process by Device 
       [0133]    The overall flow of one example of the process by the device is shown in  FIGS. 15 and 16 . In the judgment in the following flowchart, down refers to Yes and right (left) refers to No unless specifically written as “Yes” and “No”. The processes described below are all processes controlled by the control member  77  and the body controller  10 . 
         [0134]    When the power of the device body  20  is turned ON, initialization of the body controller  10  is performed (step S 1 ). In this initialization operation, initialization of the program, return to an origin position for the driving member of the device body  20 , and the like are performed. 
         [0135]    When the power of the data processing unit  12  or the personal computer is turned ON, initialization of the control member  77  is performed (step S 201 ). In this initialization operation, initialization of the program or the like is performed. After the initialization is completed, a menu screen (not shown) including an input screen display button for instructing the display of an input screen is displayed on the display member  79 . The user can operate the input member  78  to select the input screen button for instructing the display of the input screen of the menu screen. 
         [0136]    In step S 202 , the control member  77  of the data processing unit  12  determines whether or not the input screen is being displayed. The control member  77  advances the process to step S 205  if determined that the input screen is being displayed (Yes), and advances the process to step S 203  if determined that the input screen is not being displayed (No). 
         [0137]    In step S 203 , the control member  77  of the data processing unit  12  determines whether or not a display instruction of the input screen has been made (that is, whether or not input screen button for instructing the display of the input screen of the menu screen is selected). The control member  77  advances the process to step S 204  if determined that the display instruction of the input screen has been made (Yes), and advances the process to step S 301  if determined that the display instruction of the input screen has not been made (No). 
         [0138]    In step S 204 , the control member  77  of the data processing unit  12  displays the input screen on the display member  79 . 
         [0139]    In step S 205 , the user operates the input member  78  to input sample information such as ID number and age of the cancer patient to be examined. Thereafter, in step S 206 , the information input with the input member  78  are stored in the hard disc  91   g . The instruction to start the measurement is made by having the user operate the input member  78  of the personal computer  12  and select a start button displayed on the input screen. 
         [0140]    In step S 207 , the control member  77  determines whether or not the instruction to start the measurement is made. The control member  77  advances the process to step S 208  if determined that the instruction to start the measurement is made (Yes), and advances the process to step S 301  if determined that the instruction to start the measurement is not made (No). In step S 208 , a measurement start signal is transmitted from the control member  77  to the body controller  10 . 
         [0141]    In step S 2 , the body controller  10  determines whether or not the measurement start signal is received. The body controller  10  advances the process to step S 3  if determined that the measurement start signal has been received (Yes), and advances the process to step S 8  if determined that the measurement start signal has not been received (No). 
         [0142]    In step S 3 , the process to prepare the specimen for expression level measurement is performed. The sample is aspirated from the sample container set in the first reagent setting member  5  in step S 3 . A predetermined process is performed on the aspirated sample, and the specimen for expression level measurement is prepared. 
         [0143]    In step S 4 , the process to prepare the specimen for activity value measurement is performed. The sample is aspirated from the sample container set in the first reagent setting member  5 . A predetermined process is performed on the aspirated sample, and the specimen for activity value measurement is prepared. 
         [0144]    In step S 5 , the tip setting member  1  set with the solid phase tip for protein  101  including the specimen for expression level measurement and the specimen for activity value measurement is moved into the detecting member  4  from the position shown in  FIG. 1 . 
         [0145]    In step S 6 , excitation light is irradiated on each well of the solid phase tip for protein  101 , and fluorescence radiated from each specimen is detected. 
         [0146]    In step S 7 , the detected detection result is transmitted from the body controller  10  to the control member  77  of the personal computer  12 . 
         [0147]    In step S 209 , the control member  77  determines whether or not the detection result is received. The control member  77  advances the process to step S 210  if determined that the detection result has been received (Yes). The control member  77  again executes the process of step S 209  if determined that the detection result has not been received (No). 
         [0148]    In step S 210 , the control member  77  executes an analyzing process from the acquired detection result. 
         [0149]    In step S 211 , the control member  77  outputs the specific activity of each CDK and result of recurrence rate calculated in step S 210  and the created distribution diagram as result of analysis, and displays the same on the display member  79 . 
         [0150]      FIG. 20  shows one example of a display screen. In the display screen shown in  FIG. 20 , ID number, age, and the like of the cancer patient to be examined are displayed on a display region  601  as information on the cancer patient to be examined. The CDK1 specific activity value and the CDK2 specific activity value of the malignant tumor of the cancer patient to be examined are displayed on an information display region  602  as information on the cancer patient to be examined. A graph having the CDK1 specific activity or first parameter and the CDK 2 specific activity or the second parameter of the malignant tumor of the cancer patient as two axes is displayed on a distribution diagram display region  603 . The result of recurrence rate calculated in step S 210  is displayed on an information display region  604  as information related to recurrence. 
         [0151]    In step S 301 , the control member  77  determines whether or not an input screen of the set values of the value (radius) for determining the sample data extraction range is being displayed. The control member  77  advances the process to step S 305  if determined that the input screen of the set value is being displayed (Yes), and advances the process to step S 302  if determined that the input screen of the set value is not being displayed (No). 
         [0152]    In step S 302 , the control member  77  determines whether or not a display instruction of the input screen of the set value has been made. The control member  77  advances the process to step S 303  if determined that the display instruction of the input screen of the set value has been made (Yes), and advances the process to step S 307  if determined that the display instruction of the input screen of the set value has not been made (No). 
         [0153]    In step S 303 , the RAM  91   g  of the control member  77  reads out data of the value (radius) for determining the sample data extraction range stored in the first database  91   i  of the hard disc  91   g.    
         [0154]    In step S 304 , the input screen of the set value is displayed on the display member  79  by the control member  77 . New values are input for the set values of the value for determining the sample data extraction range by having the user operate the input member  78 . 
         [0155]    In step S 305 , the control member  77  determines whether or not the input of the set value has been made. The control member  77  advances the process to step S 306  if determined that the input of the set value has been made (Yes), and advances the process to step S 307  if determined that the input of the set value has not been made (No). 
         [0156]    In step S 306 , the input new set value is stored in the first database  91   i  of the hard disc  91   g.    
         [0157]    In step S 307 , the control member  77  determines whether or not an instruction to shutdown is accepted. The control member  77  advances the process to step S 308  if determined that the instruction to shutdown is accepted (Yes), and returns the process to step S 202  if determined that the instruction to shutdown is not accepted (No). In step S 308 , a shutdown signal is transmitted from the control member  77  to the body controller  10 . In step S 309 , the control member  77  performs the process of shutting down the personal computer  12 , and completes the process. 
         [0158]    In step S 8 , the body controller  10  determines whether or not the shutdown signal has been received. The body controller  10  advances the process to step S 9  if determined that the shutdown signal has been received (Yes), and returns the process to step S 2  if determined that the shutdown signal has not been received (No). In step S 9 , the body controller  10  shuts down the device body  20 , and terminates the process. 
       (4) Preparation Process of Expression Level Measurement Specimen 
       [0159]    The flow of one example of the preparation process of the expression level measurement specimen in step S 3  is shown in  FIG. 17 . 
         [0160]    First, in step S 21 , the preservation solution stored in advance in each well of the solid phase tip for protein is discharged, and the inside of each well is washed. The washing is performed by injecting washing liquid to each well from the upper side through the pipette of the dispensing mechanism member  3 , and aspirating the injected washing liquid through the porous film by negative pressure from the lower side of the solid phase tip for protein. The following washing step is similarly carried out. 
         [0161]    The sample for the expression level measurement is aspirated with the pipette from the sample container set in the first reagent setting member  5 , which sample is injected to a plurality of predetermined wells, and the sample is aspirated by negative pressure from the lower side of the solid phase tip for protein. The protein is solid-phased at the porous film of the solid phase tip for protein (step S 22 ). 
         [0162]    Similar to step S 21 , the inside of the predetermined well is washed with the washing liquid. Accordingly, the components other than the protein are removed from the porous film of the solid phase tip for protein (step S 23 ). 
         [0163]    Subsequently, the blocking liquid is injected to the predetermined well, and after leaving it for 15 minutes or longer (e.g., for 30 minutes), the blocking liquid remaining in the well is discharged (step S 24 ). Accordingly, the fluorescence labeled CDK1 antibody (fluorescence labeled CDK1 antibody) and the fluorescence labeled CDK2 antibody (fluorescence labeled CDK2 antibody) are prevented from being solid-phased at the site of the porous film at which the protein is not solid-phased. The commercially available fluorescence labeled CDK1 antibody and the fluorescence labeled CDK2 antibody may be used. 
         [0164]    The fluorescence labeled CDK1 antibody and the fluorescence labeled CDK2 antibody are respectively injected to the predetermined well. In this case, each fluorescence labeled antibody is injected into two wells. The injected fluorescence label is discharged after 20 to 30 minutes have elapsed and the reaction of the fluorescence labeled antibody and the protein (CDK1 or CDK2) solid-phased on the porous film is terminated (step S 25 ). 
         [0165]    Lastly, similar to step S 23 , the inside of the predetermined well is washed with the washing liquid (Step S 26 ). 
       (5) Preparation Process of Activity Value Measurement Specimen 
       [0166]      FIG. 18  shows a flow of one example of the preparation process of the activity value measurement specimen in step S 4 . In the preparation process of the activity value measurement specimen, four specimen preparation members  211  are arranged on the near side in the figure and four specimen preparation members  211  are arranged on the far side in the figure as the activity measurement unit  2  shown in  FIG. 1 . Each specimen preparation member  211  of the activity measurement unit  2  includes a first specimen preparation member (Ac 1 ), a second specimen preparation member (Ac 2 ), a third specimen preparation member (Ac 3 ), and a fourth specimen preparation member (Ac 4 ), from the left on the far side of the figure, and a fifth specimen preparation member (Ac 5 ), a sixth specimen preparation member (Ac 6 ), a seventh specimen preparation member (Ac 7 ), and an eighth specimen preparation member (Ac 8 ), from the left on the near side of the figure. 
         [0167]    For each of the first to the eighth specimen preparation members (Ac 1  to Ac 8 ), a buffer or a washing reagent is injected to the opening  205  with the pipette of the dispensing mechanism member  3 . For each of the first to the eighth specimen preparation members (Ac 1  to Ac 8 ), the syringe pump  214  and the electromagnetic valve  225  operate as described above, so that the buffer of the liquid storage member  204  passes through the carrier  206  into the flow channel  223 , and again passes through the carrier  206  and returns to the liquid storage member  204 . The buffer returned to the liquid storage member  204  in all the columns  201  is aspirated and discarded with the pipette of the dispensing mechanical member  3  (step S 31 ). 
         [0168]    Immunoprecipitation (immunoreaction between antibody and CDK) is then performed (step S 32 ). First, the sample  1  for the activity value measurement is aspirated with one pipette and the sample  2  for the activity value measurement is aspirated with another pipette from one sample container set in the first reagent setting member  5 . 
         [0169]    As shown in  FIG. 26 , the sample  1  for the activity value measurement aspirated from the sample container is first injected to the liquid storage member  204  of the first specimen preparation member (Ac 1 ). The sample  1  is sent to the carrier  206  of the first specimen preparation member (Ac 1 ) by operating the syringe pump  214  and the electromagnetic valve  225  as described above. In this case, the sample  1  reciprocates in the carrier  206  of the column  201  once by reciprocating the piston  218  up and down once (aspiration→discharge). 
         [0170]    The sample  2  for activity value measurement aspirated from the sample container is first injected to the liquid storage member  204  of the fifth specimen preparation member (Ac 5 ). The sample  2  is similarly sent to the carrier  206  of the fifth specimen preparation member (Ac 5 ), similar to the above. 
         [0171]    Neither antibody of the CDK1 nor antibody of the CDK2 is immobilized on the carrier  206  of the columns  201  of the first specimen preparation member (Ac 1 ) and the fifth specimen preparation member (Ac 5 ). Therefore, the CDK1 and the CDK2 are not solid-phased in the first specimen preparation member (Ac 1 ) and the fifth specimen preparation member (Ac 5 ), the sample  1  containing the CDK1 and the CDK2 is stored in the column  201  of the first specimen preparation member (Ac 1 ), and the sample  2  containing the CDK1 and the CDK2 is stored in the column  201  of the fifth specimen preparation member (Ac 5 ). 
         [0172]    The sample  1  stored in the column  201  of the first specimen preparation member (Ac 1 ) is then aspirated with the pipette, and injected to the liquid storage member  204  of the third specimen preparation member (Ac 3 ). The sample  1  is then sent to the carrier  206  of the third specimen preparation member (Ac 3 ), similar to the above. 
         [0173]    The sample  2  stored in the column  201  of the fifth sample specimen member (Ac 5 ) is aspirated with the pipette, and injected to the liquid storage member  204  of the fourth specimen preparation member (Ac 4 ). The sample  2  is then sent to the carrier  206  of the fourth specimen preparation member (Ac 4 ), similar to the above. 
         [0174]    The antibody of the CDK1 is immobilized to the carriers  206  of the columns  201  of the third specimen preparation member (Ac 3 ) and the fourth specimen preparation member (Ac 4 ). Therefore, the CDK1 is solid-phased but the CDK2 is not solid-phased in the third specimen preparation member (Ac 3 ) and the fourth specimen preparation member (Ac 4 ), the sample  1  not containing the CDK1 but containing the CDK2 is stored in the column  201  of the third specimen preparation member (Ac 3 ), and the sample  2  not containing the CDK1 but containing the CDK2 is stored in the column  201  of the fourth specimen preparation member (Ac 4 ). 
         [0175]    The sample  1  stored in the column  201  of the third specimen preparation member (Ac 3 ) is then aspirated with the pipette, and injected to the liquid storage member  204  of the seventh specimen preparation member (Ac 7 ). The sample  1  is then sent to the carrier  206  of the seventh specimen preparation member (Ac 7 ), similar to the above. 
         [0176]    The sample  2  stored in the column  201  of the fourth specimen preparation member (Ac 4 ) is aspirated with the pipette, and injected to the liquid storage member  204  of the eighth specimen preparation member (Ac 8 ). The sample  2  is then sent to the carrier  206  of the eighth specimen preparation member (Ac 8 ), similar to the above. 
         [0177]    The antibody of the CDK2 is immobilized to the carrier  206  of the columns  201  of the seventh specimen preparation member (Ac 7 ) and the eighth specimen preparation member (Ac 8 ). Therefore, the CDK2 is solid-phased in the seventh specimen preparation member (Ac 7 ) and the eighth specimen preparation member (Ac 8 ), and thus the sample  1  not containing the CDK1 nor the CDK2 is stored in the column  201  of the seventh specimen preparation member (Ac 7 ), and the sample  2  not containing the CDK1 nor the CDK2 is stored in the column  201  of the eighth specimen preparation member (Ac 8 ). 
         [0178]    The sample  1  and the sample  2  stored in the columns  201  of the seventh specimen preparation member (Ac 7 ) and the eighth specimen preparation member (Ac 8 ) are respectively aspirated with the pipette, and disposed in the waste bath  7 . 
         [0179]    The first specimen preparation member (Ac 1 ) and the fifth specimen preparation member (Ac 5 ) are used for activity measurement of the background, the third specimen preparation member (Ac 3 ) and the fourth specimen preparation member (Ac 4 ) are used for activity measurement of the CDK1, and the seventh specimen preparation member (Ac 7 ) and the eighth specimen preparation member (Ac 8 ) are used for activity measurement of the CDK2. 
         [0180]    Therefore, the background activity measurement, the CDK1 activity measurement, and the CDK2 activity measurement can be performed with small amount of sample by injecting the sample remaining in the column into other columns. 
         [0181]    The buffer  1  is then sent to the columns  201  to wash and remove unnecessary components in the sample (step S 33 ). 
         [0182]    Subsequently, since the buffer  1  influences enzyme reaction executed in step S 25 , the buffer  2  is sent to the column  201  to wash off the components of the buffer  1  with the main aim of creating a condition for the relevant enzyme reaction (step S 34 ). 
         [0183]    The substrate reaction solution containing substrate Histon H 1  and ATPγS is then injected to the column  201 , and the piston  219  is allowed to reciprocate once (step S 35 ). The liquid pushed out from the lower side of the column  201  is stored in the column  201  as it is. According to such step, the phosphate group is introduced to the Histon H 1  with CDK1 and CDK2 as enzymes. The amount of phosphate group is influenced by the strength (i.e., activity value) of the work of the CDK1 or the CDK2 as enzyme, and thus the activity values of the CDK1 or the CDK2 can be obtained by measuring the amount of phosphate group. The background activity value obtained using the first specimen preparation member (Ac 1 ) and the fifth specimen preparation member (Ac 5 ) shown in  FIG. 26  is used to perform background correction as hereinafter described. 
         [0184]    The fluorescent labeled reagent is dispensed directly into the column  201  from the upper of the column  201  with the pipette to bind the fluorescent labeled substance to the phosphate group introduced into the Histon H 1  (step S 36 ). In this case, the pipette repeats aspiration and discharge of liquid in the column for a predetermined time to stir the liquid in the column  201 . 
         [0185]    A reaction stopping solution is directly dispensed to the column  201  similar to the fluorescent labeled reagent after elapse of a predetermined time (e.g., for twenty minutes) from the start of step S 26 . The liquid in the column  201  is stirred by repeating aspiration and discharge of the liquid in the column for a predetermined time similar to step S 26  (step S 37 ). The binding of fluorescent label is thereby stopped. 
         [0186]    The liquid in the columns  201  of the first specimen preparation member (Ac 1 ), the third specimen preparation member (Ac 3 ), the fourth specimen preparation member (Ac 4 ), the fifth specimen preparation member (Ac 5 ), the seventh specimen preparation member (Ac 7 ), and the eighth specimen preparation member (Ac 8 ) are injected to six wells of the solid phase tip for protein  101 , and the solid phase tip for protein  101  is aspirated from the lower side (step S 38 ). The Histon H 1  containing phosphate group bound with fluorescent labeled substance is thereby solid-phased on the porous film of the phase tip for protein  101 . 
         [0187]    The well is washed similar to step S 21  in the preparation process of expression level measurement specimen (step S 39 ). 
         [0188]    Lastly, an operation of dispensing and discharging quenching reagent for quenching (background quenching) the fluorescent light based on the fluorescent labeled substance that did not bind to the phosphate group introduced into the Histon H 1  into wells is repeated six times (step S 40 ). 
       (6) Analyzing Process 
       [0189]    As shown in the flowchart of  FIG. 19 , in the step of analyzing process (step S 210 ), analysis is performed from the fluorescence intensity obtained in the detecting member, and the result of analysis is output to the display member  79 . 
         [0190]    First, in step S 401 , the control member  77  acquires two fluorescence intensities for each of activity of CDK1, expression of CDK1, activity of CDK2, expression of CDK2, activity of background, and expression of background through the body controller  10  from the light receiving system of the detecting member  4 . 
         [0191]    Thereafter, the control member  77  calculates the average value of the fluorescence intensities obtained two at a time for each item in step S 402 . 
         [0192]    In step S 403 , the background activity (average value) is subtracted from the fluorescence intensity (average value) of the CDK1 activity. The background activity (average value) is subtracted from the fluorescence intensity (average value) of the CDK2 activity. The background correction is thereby performed for the CDK1 activity and the CDK2 activity. The background correction is similarly performed for the CDK1 expression and the CDK2 expression. 
         [0193]    In step S 404 , the control member  77  acquires the expression level and the activity value by using standard curve for each item. The standard curve is data for converting fluorescence intensity to expression level or activity value. The standard curve is created in advance by using two or more types of samples which expression level or activity value is known when the lot of the reagent is changed, and stored in the hard disc  91   g  of the control member  77 . 
         [0194]    In step S 405 , the control member  77  calculates the CDK1 specific activity and the CDK2 specific activity according to equation (III): 
         [0000]      CDK1 specific activity=CDK1 activity value/CDK1 expression level 
         [0000]      And equation (IV): 
         [0000]      CDK2 specific activity=CDK2 activity value/CDK2 expression level 
         [0195]    Thereafter, in step S 406 , the control member  77  creates a distribution diagram having a logarithm (log) of the CDK1 specific activity and a logarithm (log) of the CDK2 specific activity on two axes, and determines the sample data extraction range based on the calculated CDK1 specific activity and CDK2 specific activity. The sample data extraction range is a predetermined numerical range including the CDK1 specific activity and the CDK2 specific activity of the malignant tumor of the cancer patient to be examined. Specifically, the sample data extraction range is determined as a circle having a radius of 0.3 with a point corresponding to the logarithm (log) of the CDK1 specific activity and the logarithm (log) of the CDK2 specific activity of the malignant tumor of the cancer patient to be examined as a center in the distribution diagram having the logarithm (log) of the CDK1 specific activity and the logarithm (log) of the CDK2 specific activity on two axes. The value of radius corresponds to the numerical values of the horizontal axis and the vertical axis in the distribution diagram. 
         [0196]    The CDK1 specific activity and the CDK2 specific activity of the malignant tumor of the cancer patient to be examined are collectively referred to as “data on cancer patient to be examined”. 
         [0197]    In step S 407 , the control member  77  reads out sample data in which the measurement value such as activity value and expression level of the cancer patient and the clinical information on the relevant patient are corresponded from the second database  91   j  of the hard disc  91   g.    
         [0198]    In step S 408 , the control member  77  extracts the sample data based on the sample data extraction range determined in step S 406 . 
         [0199]    In step S 409 , the control member  77  calculates a recurrence rate based on the sample data extracted in step S 408 . Specifically, the recurrence rate can be calculated by counting the total number of sample data extracted in step S 408  and calculating the proportion of the sample data related to the patient in whom the cancer recurred, of the sample data. The recurrence rate is shown in percentage (%) with the total number of sample data as 100. 
         [0200]    In step S 211 , the control member  77  executes a process for displaying a screen as shown in  FIG. 20  on the display member. The screen includes an identification information display region  601 , a CDK data display region  602 , a distribution diagram display region  603 , and a recurrence rate display region  604 . 
         [0201]    The identification information display region  601  displays ID number and age of the cancer patient to be examined as information on the cancer patient to be examined. 
         [0202]    The CDK data display region  602  displays the CDK1 specific activity and the CDK2 specific activity of the malignant tumor of the cancer patient to be examined as information on the cancer patient to be examined. 
         [0203]    The recurrence rate display region  604  displays the recurrence rate calculated in step S 210 . 
         [0204]    The distribution diagram display region  603  displays a graph having the CDK1 specific activity and the CDK2 specific activity as two axes. On the distribution diagram, the sample data ( 401 ,  402 ) of the cancer patient administered with anthracycline anticancer drugs of the sample data stored in the storage member are drawn. 
         [0205]    The sample data  401  is plotted with sample data of the patient in whom the cancer recurred by the 1500 th  day after being administered with the anthracycline anticancer drug. The sample data of the patient in whom the cancer recurred is displayed by dots surrounded by a circle as shown in  FIG. 20 . The sample data  402  is plotted with sample data of the patient in whom recurrence of cancer is not recognized after being administered with the anthracycline anticancer drug. The sample data of the patient in whom recurrence of cancer is not recognized is displayed only by dots as shown in  FIG. 20 . 
         [0206]    The data on cancer patient to be examined  400  is plotted on the distribution diagram. 
         [0207]    A sample data extraction range  403  determined in S 406  is displayed on the distribution diagram. The distribution diagram of the display screen shown in  FIG. 20  displays the CDK1 specific activity on the horizontal axis by log and the CDK2 specific activity on the vertical axis by log. 
         [0208]    Taking the graph shown in  FIG. 20  by way of example, the sample data of the cancer patient in whom the cancer recurred by the 1500 th  day after being administered with the anthracycline anticancer drug tends to concentrate at a specific region of the graph (middle in the graph of  FIG. 20 ). The data on cancer patient to be examined  400  is positioned in a region where the sample data of the patient in whom the cancer recurred concentrates. Therefore, the state of the malignant tumor of the cancer patient to be examined can be predicted to be a state similar to the malignant tumor of the cancer patient in whom the cancer recurred after being administered with the anthracycline anticancer drug. The result of calculating the recurrence rate based on the total number of sample data contained in the sample data extraction range  403  determined on the basis of the data on cancer patient to be examined  400  and the proportion of the sample data of the cancer patient in whom the recurrence of cancer is recognized is as displayed on the recurrence rate display region  604 . In the example shown in  FIG. 20 , the recurrence rate of cancer in the cancer patient to be examined is 63%. 
         [0209]    As shown in  FIG. 20 , the sample data of the patient administered with the anthracycline anticancer drug and in whom recurrence of cancer is recognized is distributed concentrating on the specific region of the two-axle graph based no the CDK1 specific activity and the CDK2 specific activity. That is, the features of the anticancer effect by the anthracycline anticancer drug are reflected on the two-axes graph of the CDK1 specific activity and the CDK2 specific activity. Thus, the sample data of the cancer patient having a specific feature in the anticancer effect by the anthracycline anticancer drug can be extracted by plotting the data cancer patient to be examined on such two-axes graph and extracting the sample data based on the plotted data on cancer patient to be examined, and thus the recurrence rate reflecting the state of the malignant tumor of the cancer patient to be examined can be obtained by calculating the recurrence rate of the cancer in the cancer patient to be examined based on the information related to the recurrence of cancer contained in the extracted sample data. 
         [0210]    Therefore, the information on the recurrence rate provided by the device according to the first embodiment is information useful in predicting the effectiveness of the anthracycline anticancer drug in the cancer patient to be examined, and is information also useful in determining the treatment policy of the cancer patient to be examined. Therefore, the user can obtain diagnosis support information at higher precision by the diagnosis support device according to the first embodiment. 
         [0211]    The device of the first embodiment is configured including the measurement unit  501  for measuring the activity value and the expression level of the CDK1 as well as the activity value and the expression level of the CDK2, and the solubilizing device B for obtaining a sample that can be processed in the measuring device A from a biological specimen (malignant tumor), but is not limited to such configuration. For instance, a configuration of inputting the activity values and the expression levels of the CDK1 and the CDK2 separately measured by other methods or other devices from the malignant tumor of the cancer patient to be examined through the personal computer, and performing analysis by using the input values may be adopted. Alternatively, a configuration of obtaining the CDK1 specific activity and the CDK2 specific activity in advance from the separately measured activity value and the expression level, and performing analysis by accepting the input of such values may be adopted. 
         [0212]    The first embodiment has a configuration in which the control member  77  acquires two fluorescence intensities for each of the activity of the CDK1, the expression of the CDK1, the activity of the CDK2, the expression of the CDK2, the activity of the background, and the expression of the background, and calculates the average value of the fluorescence intensity obtained by twos for each item, but is not limited thereto, and may have a configuration in which the control member  77  acquires three or more fluorescence intensities for each of the activity of the CDK1, the expression of the CDK1, the activity of the CDK2, the expression of the CDK2, the activity of the background, and the expression of the background, and calculates the average value of the fluorescence intensity of each item. 
         [0213]    One fluorescence intensity for each of the activity of the CDK1, the expression of the CDK1, the activity of the CDK2, the expression of the CDK2, the activity of the background, and the expression of the background may be acquired. In this case, the background correction of the activity and the expression of the CDK1 and the activity and the expression of the CDK2 is performed using the fluorescence intensity of each item acquired by one instead of the average value of each item in step S 403 . 
         [0214]    In the first embodiment, the control member  77  calculates the CDK1 specific activity and the CDK2 specific activity in step S 405 , but the present invention is not limited thereto. For instance, in step S 405 , the control member  77  may calculate the inverse number of the CDK1 specific activity and the increase number of the CDK2 specific activity according to the following equation (V) in place of the CDK1 specific activity and the CDK2 specific activity: 
         [0000]      Inverse number of CDK1 specific activity=CDK1 expression level/CDK1 activity value 
         [0000]      and equation (VI) 
         [0000]      Inverse number of CDK2 specific activity=CDK2 expression level/CDK2 activity value 
         [0215]    The device of the first embodiment is configured such that the user such as doctor appropriately sets the radius of the sample data extraction range, and the sample data extraction range is determined as a circle having the set radius. The sample data extraction range is desirably determined to a size that the minimum required number of samples for ensuring the statistical reliability can be ensured. Therefore, from the standpoint of ensuring reliability, the information on the number of samples contained in the sample data extraction range may be displayed simultaneously with the display of the sample data extraction range on the display screen so that the minimum required number of samples can be ensured in the sample data extraction range. The user can then easily reset the radius of the sample data extraction range so that an appropriate number of samples can be ensured with reference to the information on the number of samples displayed on the screen. 
         [0216]    The device of the first embodiment may automatically determine the radius of the sample data extraction range. If the device automatically sets the radius, a configuration of determining the sample data extraction range so as to satisfy the following conditions (I) to (III) is preferable. 
         [0217]    (I) Having a range from which sample data of medically and statistically meaningful number can be extracted with the data on cancer patient to be examined as the center; 
         [0218]    (II) Setting a region including the data on cancer patient to be examined and having a size capable of including the measurement error/standard deviation by the device; 
         [0219]    (III) Setting a region including the data on cancer patient to be examined, and having a predetermined size including the measurement error/standard deviation of the CDK1 specific activity and the CDK2 specific activity obtained by performing one or more measurements with respect to one predetermined item for one specimen. 
         [0220]    The diagnosis support information having medical meaning and having high precision can be provided by determining the sample data extraction range as in (I) by the control member  77 . The lowering in precision caused by the measurement error by the device can be prevented by determining the sample data extraction range as in (II) by the control member  77 . The lowering in precision caused by variation in the measurement values by the measurement method can be prevented by determining the sample data extraction range as in (III) by the control member  77 . In step S 406 , the sample data extraction range is determined as above, and thus information useful in predicting the effectiveness of the anthracycline anticancer drug can be provided at high precision. 
         [0221]    In the device of the first embodiment, the sample data extraction range is a circle having the data on cancer patient to be examined as the center, but is not limited thereto. The sample extraction range may be other shapes such as square or ellipse having the data on cancer patient to be examined as the center. 
         [0222]    In the device of the first embodiment, the sample data extraction range is appropriately determined based on the data on cancer patient to be examined, but is not limited to such configuration. For instance, the numerical range related to the CDK1 specific activity and the CDK2 specific activity that may be the candidates of the sample data extraction range may be set in plurals in advance, and the numerical range to which the data on cancer patient to be examined belongs, of the numerical ranges, may be determined as the sample data extraction range. There may be a configuration of setting, as such numerical range, a reference value to the CDK1 specific activity and the CDK2 specific activity that can divide the cancer patients administered with the anthracycline anticancer drugs into at least two groups of different recurrence risks, and setting two ranges of the range of greater than or equal to the reference value and the range smaller than the reference value. 
         [0223]    The reference value can be set to a statistically significant value by obtaining the CDK1 specific activity and the CDK2 specific activity of the malignant tumor of the cancer patient administered with the anthracycline anticancer drugs from a plurality of cases. Second and third embodiments using the reference value obtained in such manner are described below. 
       Second Embodiment 
       [0224]      FIG. 21  is a schematic explanatory view of a graph shown in the distribution diagram display region in the display screen of the diagnosis support device of the second embodiment. In the diagnosis support device of the second embodiment, the reference value is set in advance based on the activity values and the expression levels of the CDK1 and the CDK2. In  FIG. 21 , a reference line  416  based on the reference value is drawn. In  FIG. 21 , the sample data ( 414 ,  415 ) of the cancer patient administered with the anthracycline anticancer drug are drawn. 
         [0225]    The sample data  414  is plotted with the sample data of the cancer patient in whom the cancer recurred by the 1500 th  day after being administered with the anthracycline anticancer drug. The sample data  415  is plotted with the sample data of the cancer patient in whom the recurrence of cancer is not recognized after being administered with the anthracycline anticancer drug. Furthermore, data on cancer patient to be examined  410  is plotted in  FIG. 21 . 
         [0226]    A region  411 , B region  412 , and C region  413  are obtained as the sample data extraction range by the reference value (reference line)  416  of  FIG. 21 . The recurrence rate of the cancer in each sample data extraction range is calculated based on the presence of recurrence of the sample data contained in each sample data extraction range. This result is shown in table 2. 
         [0000]    
       
         
               
               
               
               
             
               
               
               
               
             
           
               
                 TABLE 2 
               
               
                   
               
               
                   
                 Total number of sample 
                 Number of recurred 
                   
               
               
                 Region 
                 data 
                 sample data 
                 Recurrence rate 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 A 
                 12 
                 1 
                 8% 
               
               
                 B 
                 28 
                 16 
                 57% 
               
               
                 C 
                 14 
                 2 
                 14% 
               
               
                   
               
             
          
         
       
     
         [0227]    As shown in table 2, the recurrence rate of the A region is 8%, the recurrence rate of the B region is 57%, and the recurrence rate of the C region is 14%. In the example shown in  FIG. 21 , the data on cancer patient to be examined  410  is plotted in the region (B region) where the sample data of the cancer patient in whom the recurrence of cancer is recognized is concentrated. Thus, the state of the malignant tumor of the cancer patient to be examined can be assumed as a state similar to the malignant tumor of the cancer patient in whom the cancer recurred after being administered with the anthracycline anticancer drug. The data on cancer patient to be examined  410  belongs to the B region, and thus the recurrence rate of the cancer patient to be examined is calculated as 57% from table 2. 
       Third Embodiment 
       [0228]      FIG. 22  is a schematic explanatory view of a graph shown in the distribution diagram display region in the display screen of the diagnosis support device of the third embodiment. In the diagnosis support device of the third embodiment, the reference value  426  is set in advance based on the information related to recurrence contained in the sample data of the cancer patient administered with the anthracycline anticancer drug. In  FIG. 22 , the reference value  426  (reference line) is drawn. In  FIG. 22 , the sample data ( 424 ,  425 ) of the cancer patient administered with the anthracycline anticancer drug are plotted. Specifically, the sample data  424  is plotted with the sample data of the cancer patient in whom the cancer recurred by the 1500 th  day after being administered with the anthracycline anticancer drug. The sample data  425  is plotted with the sample data of the cancer patient in whom the recurrence of cancer is not recognized after being administered with the anthracycline anticancer drug. Furthermore, data on cancer patient to be examined  420  is plotted in  FIG. 22 . 
         [0229]    A region  421 , B region  422 , and C region  423  are obtained as the sample data extraction range by the reference value (reference line)  426  of  FIG. 22 . The result of calculating the recurrence rate based on the presence of recurrence of cancer of the sample data contained in each sample data extraction range divided as above is shown in table 3. 
         [0000]    
       
         
               
               
               
               
             
               
               
               
               
             
           
               
                 TABLE 3 
               
               
                   
               
               
                   
                 Total number of sample 
                 Number of recurred 
                   
               
               
                 Region 
                 data 
                 sample data 
                 Recurrence rate 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 A 
                 12 
                 1 
                 8% 
               
               
                 B 
                 14 
                 3 
                 21% 
               
               
                 C 
                 28 
                 14 
                 50% 
               
               
                   
               
             
          
         
       
     
         [0230]    As shown in table 3, the recurrence rate of the A region is 8%, the recurrence rate of the B region is 21%, and the recurrence rate of the C region is 50%. In the example shown in  FIG. 22 , the data on cancer patient to be examined  420  is plotted in the region (C region) where the sample data of the cancer patient in whom the cancer recurred is concentrated. Thus, the state of the malignant tumor of the cancer patient to be examined can be assumed as a state similar to the malignant tumor of the cancer patient in whom the cancer recurred after being administered with the anthracycline anticancer drug. The data cancer patient to be examined  420  belongs to the C region, and thus the recurrence rate of the cancer patient to be examined is calculated as 50% from table 3. 
         [0231]    A reference value for classifying the cancer patient not treated with anticancer drug into groups of different recurrence risks may be set. An example using such reference value is shown in  FIG. 24 .  FIG. 24  is a graph showing the cancer patient not treated with anticancer drug classified into three groups of different recurrence risks. 
         [0232]    In  FIG. 24 , a reference value  446  capable of dividing the cancer patients treated with hormone therapy without being treated with anticancer drug into three groups of different recurrence risks is shown. The reference value  446  is calculated based on the sample data ( 444 ,  445 ) of the cancer patient treated with hormone therapy. Specifically, the sample data  444  is plotted with the sample data of the cancer patient in whom the cancer recurred by the 1500 th  day after being treated with hormone therapy. The sample data  445  is plotted with the sample data of the cancer patient in whom the recurrence of cancer is not recognized after being treated with the hormone therapy. 
         [0233]    The reference value  446  in  FIG. 24  includes a first reference value, a second reference value, a third reference value, and a fourth reference value. Specifically, the reference values are as described below. 
         [0234]    First reference value: ratio (specific activity ratio) of CDK1 specific activity and CDK2 specific activity is 2.8 
         [0235]    Second reference value: specific activity of CDK1 is 5 
         [0236]    Third reference value: specific activity of CDK1 is 20 
         [0237]    Fourth reference value: specific activity of CDK1 is 90 
         [0238]    The cancer patients treated with hormone therapy without being treated with anticancer drug can be divided into three groups of different recurrence risks by the reference value  446 . Specifically, the cancer patients can be classified into a high risk group H (region  441 ) in which the recurrence rate is relatively high, a low risk group L (region  443 ) in which the recurrence rate is relatively low, and an intermediate risk group I (region  442 ) in which the recurrence rate is intermediate. The recurrence rate is calculated based on the information on the presence of recurrence of the sample data of the cancer patients treated with hormone therapy contained in the high risk group H, the intermediate risk group I, and the low risk group L of the graph of  FIG. 24 . The result is shown in table 4. 
         [0000]    
       
         
               
               
               
               
             
               
               
               
               
             
           
               
                 TABLE 4 
               
               
                   
               
               
                   
                 Total number of 
                 Number of recurred 
                   
               
               
                 Risk group 
                 sample data 
                 sample data 
                 Recurrence rate 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 L 
                 73 
                 2 
                 3% 
               
               
                 I 
                 47 
                 3 
                 6% 
               
               
                 H 
                 66 
                 10 
                 15% 
               
               
                   
               
             
          
         
       
     
         [0239]    A fourth embodiment employing the reference value shown in  FIG. 24  as the reference value for classifying the cancer patient administered with the anthracycline anticancer drug into groups of different recurrence risks is described below. 
       Fourth Embodiment 
       [0240]      FIG. 23  is a schematic explanatory view of a graph shown in the distribution diagram display region in the display screen of the diagnosis support device of the fourth embodiment. In the diagnosis support device of the fourth embodiment, in the example shown in  FIG. 23 , a reference value  436  for classifying the cancer patient administered with anthracycline anticancer drug into groups of different recurrence risks is set in advance. The reference value  436  is drawn in  FIG. 23 . As described above, the reference value  436  is applied with the reference value (reference value  446  of  FIG. 24 ) for classifying the cancer patient treated with hormone therapy without being treated with anticancer drug into groups of different recurrence risks. That is, the reference value  436  in  FIG. 23  includes a first reference value, a second reference value, a third reference value, and a fourth reference value, and specifically, the reference values are as described below. 
         [0241]    First reference value: ratio (specific activity ratio) of CDK1 specific activity and CDK2 specific activity is 2.8 
         [0242]    Second reference value: specific activity of CDK1 is 5 
         [0243]    Third reference value: specific activity of CDK1 is 20 
         [0244]    Fourth reference value: specific activity of CDK1 is 90 
         [0245]    In  FIG. 23 , the sample data ( 434 ,  435 ) of the cancer patient administered with the anthracycline anticancer drug are plotted. Specifically, the sample data  434  is plotted with the sample data of the cancer patient in whom the cancer recurred by the 1500 th  day after being administered with the anthracycline anticancer drug. The sample data  435  is plotted with the sample data of the cancer patient in whom the recurrence of cancer is not recognized after being administered with the anthracycline anticancer drug. Furthermore, data cancer patient to be examined  430  is plotted in  FIG. 23 . 
         [0246]    A region  431 , B region  432 , and C region  433  are obtained as the sample data extraction range by the reference value  436  of  FIG. 23 . The recurrence rate is calculated based on the information on the presence of recurrence of the sample data of the cancer patient administered with the anthracycline anticancer drug contained in each sample data extraction range divided in the above manner. This result is shown in table 5. 
         [0000]    
       
         
               
               
               
               
             
               
               
               
               
             
           
               
                 TABLE 5 
               
               
                   
               
               
                   
                 Total number of 
                 Number of recurred sample 
                   
               
               
                 Region 
                 sample data 
                 data 
                 Recurrence rate 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 A 
                 18 
                 1 
                 6% 
               
               
                 B 
                 14 
                 6 
                 43% 
               
               
                 C 
                 22 
                 12 
                 55% 
               
               
                   
               
             
          
         
       
     
         [0247]    As shown in table 5, the recurrence rate of the A region is 6%, the recurrence rate of the B region is 43%, and the recurrence rate of the C region is 55%. From the result of  FIG. 23  and table 5, it can be seen that the sample data  434  of the cancer patient in whom the cancer recurred after being administered with anthracycline anticancer drug is barely seen in the A region. The A region  431  of  FIG. 23  corresponds to the high risk group H of  FIG. 24 . Therefore, if the data on cancer patient to be examined is contained in the A region  431 , the state of the malignant tumor of the cancer patient to be examined can be predicted as a state similar to the malignant tumor of the cancer patient in whom the cancer recurred after being treated with hormone treatment without being treated with anticancer drug, and a state similar the malignant tumor of the cancer patient in whom the cancer did not recur after being administered with the anthracycline anticancer drug. The cancer patient to be examined thus can be predicted as having high recurrence risk unless administered with anticancer drug, but recurrence can be prevented by administering the anthracycline anticancer drug. In other words, it is suggested that the anthracycline anticancer drug can be predicted to be effective for the relevant cancer patient to be examined. 
         [0248]    From the result of  FIG. 23  and table 5, it can be seen that the sample data  434  of the cancer patient in whom the cancer recurred after being administered with anthracycline anticancer drug is concentrated in the B region and the C region. The B region  432  of  FIG. 23  corresponds to the intermediate risk group I of  FIG. 24 , and the C region  433  of  FIG. 23  corresponds to the low risk group L of  FIG. 24 . Therefore, if the data on cancer patient to be examined is contained in the B region  432  or the C region  433 , the state of the malignant tumor of the cancer patient to be examined can be predicted as a state similar to the malignant tumor of the cancer patient in whom the cancer recurred after being administered with anthracycline anticancer drug. Then, it can be predicted that it is difficult to prevent recurrence even if the anthracycline anticancer drug is administered in the cancer patient to be examined. In other words, it is suggested that the anthracycline anticancer drug can be predicted to be ineffective for the relevant cancer patient to be examined. 
         [0249]    For instance, the data on cancer patient to be examined  430  is contained in the C region  433  in  FIG. 23 . Thus, the state of the malignant tumor of the cancer patient to be examined can be predicted as a state similar to the malignant tumor of the cancer patient in whom the cancer recurred after being administered with anthracycline anticancer drug. 
         [0250]    The sample data extraction range is determined as the C region  433  based on the data on cancer patient to be examined  430 , and the recurrence rate of the cancer of the cancer patient to be examined is calculated based on the information on the presence of recurrence of the sample data contained in the C region  433 . As a result, a value of high recurrence rate of 55% was indicated. 
         [0251]    Therefore, the reference value corresponding to the CDK1 specific activity and the CDK2 specific activity for classifying the cancer patients not treated with anticancer drug into groups of different recurrence risks is suggested to be used as the reference value for classifying the cancer patients administered with the anthracycline anticancer drug into groups of different recurrence risks. 
         [0252]    The recurrence rate calculated as above can be predicted as the recurrence rate reflecting the state of the malignant tumor of the cancer patient to be examined. That is, the recurrence rate calculated as above can be considered as the recurrence rate of the cancer predicted when the anthracycline anticancer drug is administered to the cancer patient to be examined. Therefore, the information on the recurrence rate provided by the device according to the fourth embodiment is information useful in predicting the effectiveness of the anthracycline anticancer drug in the cancer patient to be examined, and may be information useful in determining the treatment policy of the cancer patient to be examined. 
         [0253]    The reference values of the second to the fourth embodiments may be appropriately set by users such as doctors. 
         [0254]    In each of the second to the fourth embodiments, the sample data extraction range for extracting the sample data by displaying the set value input screen and inputting the set value is set, but is not limited to such configuration. The set value can be input with the following configuration. 
         [0255]      FIG. 27  is a view showing one example of the set value input screen. First, the cursor C is moved to a predetermined position on the distribution diagram with the operation of the input member  78  (e.g., mouse) with the distribution diagram showing the sample data displayed on the set value input screen, and the mouse is double clicked to set the first set value P 1 . Similar operation is performed to input the second set value. The mouse is then right clicked to display a selection menu M, and the item of the displayed “reference line input” is selected to set a reference line L connecting the first set value and the second set value. The reference line as shown in  FIGS. 22 and 23  can be easily set by repeating such operations. 
         [0256]    The “reference line input” is selected after inputting three or more set values by the input member  78 , so that a curve approximate to a line segment connecting each set value is set as the reference line and displayed on the distribution diagram. The reference line shown in  FIG. 21  is easily set and the setting of the sample data extraction range is facilitated through such method. 
         [0257]    [4] Prediction of Effectiveness of Anthracycline Anticancer Drug 
         [0258]    As described in [3], the information related to the recurrence obtained by the diagnosis support device is information useful in predicting the effectiveness of the anthracycline anticancer drug. The effectiveness of the anthracycline anticancer drug thus can be predicted based on the information related to the recurrence obtained by the diagnosis support device. 
         [0259]    In an effectiveness prediction device, a threshold value for predicting effectiveness (threshold value defined based on the recurrence rate obtained from the patients after being administered with anthracycline anticancer drug) may be stored in advance as a set value. Such effectiveness prediction device merely needs to be configured to calculate the recurrence rate, similar to the diagnosis support device of the first embodiment. The effectiveness prediction device also merely needs to be configured to predict the effectiveness of the anthracycline anticancer drug in the cancer patient to be examined by comparing the calculated recurrence rate and the threshold value. Specifically, the value of the recurrence rate and the threshold value are compared, and determination is made as “low effectiveness” if the value of the recurrence rate is greater than or equal to the threshold value, and determination is made as “high effectiveness” if the value of the recurrence rate is smaller than the threshold value. 
         [0260]    The effectiveness prediction device is configured to display the prediction result of effectiveness as result of analysis on the display screen for outputting (displaying) the result of analysis. An example of such display screen is shown in  FIG. 25 . In the display screen shown in  FIG. 25 , ID number, age, and the like of the cancer patient to be examined are displayed on the display region  601 . The information display region  602  also displays data on cancer patient to be examined, that is, the CDK1 specific activity and the CDK2 specific activity obtained from the malignant tumor of the cancer patient to be examined. A graph having the CDK1 specific activity and the CDK2 specific activity as two axes is displayed in the distribution diagram display region  603 . The result of the calculated recurrence rate is displayed on the information display region  604 . The determination result of effectiveness is displayed as information related to the effectiveness of the anthracycline anticancer drug in the cancer patient to be examined on the information display region  605 . 
         [0261]    With regards to other configurations and processes, the configurations and processes similar to the diagnosis support device of the first embodiment can be applied to the effectiveness prediction device. 
         [0262]    In the effectiveness prediction device, the effectiveness is predicted (determined) based on the calculated recurrence rate, but is not limited thereto. In the second to the fourth embodiments, the sample data extraction range is determined by comparing the CDK1 specific activity and the CDK2 specific activity of the data on cancer patient to be examined with the reference value set in advance. The reference value is the reference value capable of dividing the cancer patients administered with the anthracycline anticancer drug into at least two groups of different recurrence risks, and thus the effectiveness of the anthracycline anticancer drug in the cancer patient to be examined can be predicted by determining to which group divided by the reference value the data on cancer patient to be examined belongs.

Technology Classification (CPC): 6