Patent Publication Number: US-2022215906-A1

Title: Cancer medical drug treatments assay method and devices

Description:
BACKGROUND 
     The health care industry is facing difficulties with spiraling higher costs. Clinicians face having to make drug treatment choices for patients from a myriad of new drugs designed to combat a myriad of conditions and diseases. Drug treatment choices may have been through trials that do not match a particular patient&#39;s genetic response or stage of condition. A clinician needs to be aware of the clinical and cost effectiveness of all drugs or combinations of drugs before using those treatments on a patient. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows for illustrative purposes only an example of an overview of a method and devices for direct apoptosis assay of purified cells of one embodiment. 
         FIG. 2  shows a block diagram of an overview of a cancer companion diagnostic for chemotherapy of one embodiment. 
         FIG. 3  shows a block diagram of an overview flow chart of performing a cancer companion diagnostic direct apoptosis assay of purified cancer cells of one embodiment. 
         FIG. 4  shows a block diagram of an overview flow chart of receiving patient biopsy tissue sample of one embodiment. 
         FIG. 5  shows a block diagram of an overview flow chart of assaying apoptosis of purified cancer cells in culture of one embodiment. 
         FIG. 6  shows a block diagram of an overview flow chart of a direct APOP assay of purified cells of one embodiment. 
         FIG. 7  shows a block diagram of an overview of 1.0 direct APOP assay of purified cells of one embodiment. 
         FIG. 8  shows a block diagram of an overview of 1.05 purified cells+drugs of one embodiment. 
         FIG. 9  shows a block diagram of an overview of 1.1 culture and determination of antitumor activity of one embodiment. 
         FIG. 10  shows a block diagram of an overview of 2.0 using APOP for anti-inflammatory therapy of one embodiment. 
         FIG. 11  shows a block diagram of an overview of 3.0 using APOP for anti-immunological therapy of one embodiment. 
         FIG. 12  shows a block diagram of an overview of 4.0 using APOP to increase immune therapy effects of one embodiment. 
         FIG. 13  shows a block diagram of an overview of 5.0 extended APOP assay decision tree of one embodiment. 
         FIG. 14  shows a block diagram of an overview of 6.0 pre-APOP assay decision tree of one embodiment. 
         FIG. 15  shows a block diagram of an overview of 7.0 parallel APOP assay decision tree of one embodiment. 
         FIG. 16  shows a block diagram of an overview of 8.0 interpretations of APOP results for a series of drugs or combinations of one embodiment. 
         FIG. 17A  shows a block diagram of an overview of 9.0 using the APOP assay on therapy of patients with resistant or heavily pretreated cancer of one embodiment. 
         FIG. 17B  shows a block diagram of an overview of situations of one embodiment. 
         FIG. 17C  shows a block diagram of an overview of situations continued of one embodiment. 
         FIG. 18  shows a block diagram of an overview of 10.0 interpretations of APOP results for drugs or combinations based on amount of O.D. change of one embodiment. 
         FIG. 19  shows a block diagram of an overview of 11.0 interpretations of APOP results for drugs with similar mechanisms of action of one embodiment. 
         FIG. 20  shows a block diagram of an overview of 12.0 advanced interpretation of APOP results using O.D. change and maximum O.D. increase from a single drug or combination of one embodiment. 
         FIG. 21  shows a block diagram of an overview of 13.0 enhancing drug development decisions by use of APOP assay and cell growth inhibition of one embodiment. 
         FIG. 22  shows a block diagram of an overview of 14.0 a method to reduce cost of chemotherapy and/or drug therapy for cancer of one embodiment. 
         FIG. 23  shows a block diagram of an overview of cost of drugs or therapies defined of one embodiment. 
         FIG. 24A  shows a block diagram of an overview of 15.0 a method to promote immune therapy effects of immuno-active drugs and/or immune cells in treating cancer or leukemia of one embodiment. 
         FIG. 24B  shows a block diagram of an overview of 15.1 cancer or leukemia cells of one embodiment. 
         FIG. 24C  shows a block diagram of an overview of 16.0 a method to evaluate whether to consider using immunoactive drugs to treat cancer of one embodiment. 
         FIG. 25  shows a block diagram of an overview of measure immune marker before APOP assay of one embodiment. 
         FIG. 26  shows a block diagram of an overview of 15.2 APOP assay cancer cells of one embodiment. 
         FIG. 27A  shows a block diagram of an overview of 17.0 a method to identify non-equivalences of drugs of one embodiment. 
         FIG. 27B  shows a block diagram of an overview of 17.1 using the APOP assay of one embodiment. 
         FIG. 28  shows a block diagram of an overview of 18.0 a method for identifying an anti-apoptosis drug of one embodiment. 
         FIG. 29  shows for illustrative purposes only an example of direct APOP assay of purified cells application of one embodiment. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     In a following description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration a specific example in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention. 
     General Overview: 
     It should be noted that the descriptions that follow, for example, in terms of a method and devices for direct APOP assay of purified cells is described for illustrative purposes and the underlying system can apply to any number and multiple types of medical drug treatments. In one embodiment of the present invention, the method and devices for direct APOP assay of purified cells can be configured using a number of drugs for testing. The method and devices for direct APOP assay of purified cells may be configured to include a number of cell purification technologies and may be configured to include a number of next-generation sequencing technologies using the present invention. 
     The term “apoptosis” used herein refers to a genetically directed process of cell self-destruction that is marked by the fragmentation of nuclear DNA, is activated either by the presence of a stimulus or removal of a suppressing agent or stimulus, is a normal physiological process eliminating DNA-damaged, superfluous, or unwanted cells, and when halted (as by genetic mutation) may result in uncontrolled cell growth and tumor formation and additionally is expressed without any change in meaning as “APOP” in any case lower, upper or mixed. 
     The term “APOP” used herein refers to an assay to test and measure apoptosis effectiveness of a single drug or combination of drugs against purified cells including cancer cells. 
     The term “companion diagnostic” used herein refers to a diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person. 
     The term “antigen” used herein refers to a toxin or other foreign substance which induces an immune response in the body, especially the production of antibodies or a cellular response. 
     The term “Immunotherapy” used herein refers to a treatment to stimulate or restore the ability of the immune (defense) system to fight infection and disease. 
     The term “cannabinoid” used herein refers to any chemical in marijuana that causes drug-like effects all through the body, including the central nervous system and the immune system. 
     The term “CBD” used herein refers to a legal nonintoxicating cannabinoids found in cannabis and hemp. 
       FIG. 1  shows for illustrative purposes only an example of an overview of a method and devices for direct apoptosis assay of purified cells of one embodiment.  FIG. 1  shows a patient  150  providing a cancer cell biopsy  152  and DNA genomic testing  154 . The method and devices for direct apoptosis assay of purified cells processes the cancer cell biopsy  152  and DNA genomic testing  154  provided by the patient  150 . The cancer cell biopsy  152  tissues are processed in at least one cell purification procedure. The purified cells then are processed in a series of apoptosis next-generation sequence testing with selected drugs and combinations of drugs to determine which is the most effective in killing in this example the patient&#39;s cancer cells. Recommending part inhibitors as part of suggestions to doctors includes using the APOP assay with and/or without next generation sequencing, oral swabs and/or b mood in parallel to be able to assess where DNA mutations exists, for example in a tumor or also due to bloodline mutations. 
     The DNA genomic testing  154  is reviewed to identify genetic markers that show any variants in the genes that would affect the use of one or more drugs that could be used in a treatment regimen. Direct apoptosis testing results assay of a patient cancer purified cells  100  are correlated into results  110 , interpretations  120  and clinician suggested decisions  130 . The correlated apoptosis testing results assay including the results  110 , interpretations  120  and clinician suggested decisions  130  are transmitted for example to a clinician digital tablet  160 . The clinician digital tablet  160  displays the apoptosis testing results assay using an apoptosis application installed  170  on the clinician digital tablet  160 . This allows the clinician  140  to review the results, interpretations and suggested decisions with the patient  150  for planning a treatment course of one embodiment. 
     DETAILED DESCRIPTION 
       FIG. 2  shows a block diagram of an overview of a cancer companion diagnostic for chemotherapy of one embodiment.  FIG. 2  shows a cancer companion diagnostic for chemotherapy  200  used to test for cancer cell apoptosis from a single chemotherapy drug alone, or in combination with other drugs or immunotherapy  210 . The direct apoptosis testing results assay of a patient cancer purified cells  100  of  FIG. 1  in one sequencing example of the results record a measure of the level of apoptosis caused by the introduction of cannabinoids/CBD to cancer cells  220 . Also, measure increase of immune antigen stimulation treatment to kill cancer cells and release antigens to immune system  230 . Perform next generation genetic testing of tumor DNA from purified cells  235 . The direct apoptosis testing results assay of a patient cancer purified cells  100  of  FIG. 1  is used to report test results, interpretations and suggested clinician decision tree electronically with a digital application  240  to make the data available to clinicians for reviewing with patients of one embodiment. 
     Performing a Cancer Companion Diagnostic Direct Apoptosis Assay of Purified Cancer Cells: 
       FIG. 3  shows a block diagram of an overview flow chart of performing a cancer companion diagnostic direct apoptosis assay of purified cancer cells of one embodiment.  FIG. 3  shows performing a cancer companion diagnostic direct apoptosis assay of purified cancer cells  300  with descriptions of processes showing in  FIG. 4 . After performing a cancer companion diagnostic direct apoptosis assay of purified cancer cells  300  as shown in  FIG. 4  are processes for determining antitumor activity or other effects by growth inhibition or other methods  310 . Processing continues with assaying apoptosis of purified cancer cells in culture  320  with descriptions of processes showing in  FIG. 5 . After performing the processes for assaying apoptosis of purified cancer cells in culture  320  as shown in  FIG. 5  the processing continues for creating a suggested clinician decision tree using the interpretations of the direct apoptosis assay of purified cancer cells results  330 . The cancer companion diagnostic direct apoptosis assay of purified cancer cells includes reporting test results, interpretations and the suggested clinician decision tree with a digital application to a clinician&#39;s digital device  340  for allowing a clinician and patient to discuss a course of treatment based on the results of the testing for that specific patient of one embodiment. 
     Receiving Patient Biopsy Tissue Sample: 
       FIG. 4  shows a block diagram of an overview flow chart of receiving patient biopsy tissue sample of one embodiment.  FIG. 4  shows processes for the cancer companion diagnostic direct apoptosis assay of purified cancer cells  300  of  FIG. 3  that include receiving patient biopsy tissue sample  400 . The process includes using a RPMI medium or other medium with or without other additives to preserve a cancer biopsy  410 . The process includes adding antibiotics  420  to a portion of the preserved cancel biopsy. Preparation of the cancer cells for testing includes using at least one cell purification device to purify cells and sort out cancer cells  430 . 
     Individual tests on the cancer cells are performed using at least one next-generation sequencing device to perform can analyze in addition to direct apoptosis testing  440 . The direct apoptosis testing includes introducing a chemotherapy drug alone, or in combination with other drugs including cannabinoids/CBD or immunotherapy to the purified cancer cells  450 . The apoptosis effect of the chemotherapy drug alone, or in combination with other drugs including cannabinoids/CBD or immunotherapy on the purified cancer cells is determined using an optical microplate spectrophotometric reader to measure the level of apoptosis in cancer cells  460 . After the determinations of the apoptosis affects the processing returns to  FIG. 3  of one embodiment. 
     Assaying Apoptosis of Purified Cancer Cells in Culture: 
       FIG. 5  shows a block diagram of an overview flow chart of assaying apoptosis of purified cancer cells in culture of one embodiment.  FIG. 5  shows a continuation of processing from  FIG. 3  that includes assaying apoptosis of purified cancer cells in culture  320 . The process includes patient genomic testing using cells from the preserved cancer biopsy and may include analysis of patient blood sample. Effectiveness of various treatments may vary depending on the patient&#39;s genetic make-up. The assaying apoptosis processing may include analyzing patient genomic testing for detecting genetic markers associated with cancer, drug resistance or allergy  500  and in parallel to be able to assess where DNA mutations exists, for example in a tumor or also due to bloodline mutations. 
     Analyzing cancer cell apoptosis results from a single chemotherapy drug alone, or in combination with other drugs including cannabinoids/CBD or immunotherapy  510  identifies the potential success of a treatment for the single chemotherapy drug alone, or in combination with other drugs including cannabinoids/CBD or immunotherapy. Interpreting cancer cell apoptosis results from a single chemotherapy drug alone, or in combination with other drugs including cannabinoids/CBD or immunotherapy  520  assists a clinician in evaluating the testing results. Correlating analyses of genetic markers detection, cancer cell apoptosis results and interpretations of the cancer cell apoptosis results  530  is used in the processes following as described in  FIG. 3  of one embodiment. 
     A Method for Direct APOP Assay of Purified Cells: 
       FIG. 6  shows a block diagram of an overview flow chart of a method for a direct APOP assay of purified cells of one embodiment.  FIG. 6  shows a method for direct APOP assay of purified cells including performing a direct APOP assay of purified cells  600 . The method for direct APOP assay of purified cells includes performing the assays on patient purified cells to assess the effectiveness of drug treatments specific to that patient&#39;s current condition including genetics and prior treatment affects. The performing a direct APOP assay of purified cells  600  includes assaying apoptosis of purified cells passaged in culture and determination of antitumor activity or other effects by growth inhibition or other methods  610 . Using APOP for anti-inflammatory therapy (e.g., for inflammatory disease, sarcoidosis, granulomatosis diseases, arthritis, colitis, inflammatory skin diseases, myocardial diseases, lung diseases, neurological diseases, liver diseases)  620 . Using APOP for anti-immunological therapy (e.g. for autoimmune diseases, multiple sclerosis, transplant rejection)  622 . Using APOP to increase immune therapy effects (e.g. for cancer, leukemia or other neoplastic disease)  624 . Using the APOP assay on therapy of patients with resistant or heavily pretreated cancer and clinician and/or the patient is considering no further standard chemotherapy  626 . 
     The method for direct APOP assay of purified cells includes interpreting of APOP results for a series of drugs or combinations  630  for suggested clinician decisions in choosing potential treatments. The clinicians may receive the direct APOP assay and suggested clinician decisions using a direct APOP assay of purified cells application installed on a clinician&#39;s digital device including a smart phone, digital tablet and computer. The method for direct APOP assay of purified cells is used for enhancing drug development decisions by use of APOP assay and cell growth inhibition  640 , identifying non-equivalences of drugs  670 , identifying an anti-Apoptosis drug  680 , evaluating whether to consider using immunoactive drugs to treat cancer  650 , promoting immune therapy effects of immuno-active drugs and/or immune cells in treating cancer or leukemia  660  and reducing cost of chemotherapy and/or drug therapy for cancer  690  of one embodiment. 
     1.0 Direct APOP Assay of Purified Cells: 
       FIG. 7  shows a block diagram of an overview of 1.0 direct APOP assay of purified cells of one embodiment.  FIG. 7  shows a method for direct APOP assay of purified cells step 1.0 direct APOP assay of purified cells  700 . Step 1.0 direct APOP assay of purified cells  700  includes cells including 1.01 patient has a neoplasm, cancer, lymphoma, myeloma, leukemia or a mass or effusion or pleural or pericardial ascites or suspected abscess  710  and 1.02 biopsy or excision or blood sample or bone morrow sample or removal of fluid from an ascites or a pleural or pericardial effusion or ascites or abscess or spinal fluid or surgical cavity washings  720 . 1.03 cells are purified and malignant cells are separated from inflammatory or immune cells or other cells  730 . 1.04 purified cells are cultured in the APOP assay and optical density is measured over time  740 . 1.041 cells cultured may be neoplastic, inflammatory, immune, vascular, stem or glial cells  750 . The processes continue in 1.052a  760  and 1.052b  770  and are described in  FIG. 8  of one embodiment. 
     1.05 Purified Cells+Drugs: 
       FIG. 8  shows a block diagram of an overview of 1.05 purified cells+drugs of one embodiment.  FIG. 8  shows a continuation from  FIG. 7  including step 1.05  800  using 1.051 cells alone  810  and 1.052 cells+single agent chemo therapy drugs or nutrients or natural products or biological agents or hormones or targeted drugs or other molecules  811 . 1.052a cells+cannabinoid/CBD+/−THC+these drugs from 1.052 as single agents  820  and 1.052b cells+cannabinoid/CBD+/−THC+combinations of these drugs from 1.052  830 . The processes continue with 1.053 cells+combinations of these drugs  812 , 1.054 cells+cannabinoid/CBD at low dose or intermediate dose or high dose  813 , 1.055 cells+THC at low dose or intermediate dose or high dose  814  and 1.056 cells+CBD+THC  815 . The results are assessed for interpretation and suggested consideration for clinicians and/or patient see 8.0 and 10.0  840 . Additional descriptions are shown in  FIG. 17A  and  FIG. 18  of one embodiment. 
     1.1 Culture and Determination of Antitumor Activity: 
       FIG. 9  shows a block diagram of an overview of 1.1 culture and determination of antitumor activity of one embodiment.  FIG. 9  shows a continuation of steps 1.01  900 , 1.02  902  and 1.03  904  with 1.1 APOP assay of purified cells passaged in culture and determination of antitumor activity or other effects by growth inhibition or other methods  910 . 1.11 cells are cultured in short term cultures+/−growth stimulants  920  and 1.12 cells grow in culture  930 . 1.13 growth effects are evaluated as in 1.05 by cell counting or flow cytometry or genomic evolution or protein expression  940 . 1.14 cells are cultured in the APOP assay as in 1.04  950  and processed in 1.05  300  and for interpretation see 10.0  970  of one embodiment. 
     2.0 Using APOP for Anti-Inflammatory Therapy: 
       FIG. 10  shows a block diagram of an overview of 2.0 using APOP for anti-inflammatory therapy of one embodiment.  FIG. 10  shows step 2.0 using APOP for anti-inflammatory therapy (e.g., for inflammatory disease, sarcoidosis, granulomatosis diseases, arthritis, colitis, inflammatory skin diseases, myocardial diseases, lung diseases, neurological diseases, liver diseases)  1000 . 2.01 inflammatory cells from a patient or cultures (e.g. monocytes, macrophages, endothelial cells, glial cells, neutrophils, alone or in combinations)  1010 . Processing includes 2.02 APOP assay with drugs, natural products, nutrients and/or cannabinoids, NSAIDs, corticosteroids and immune modulators, experimental agents, alone or in combinations  1020 . Testing evaluation include step 2.03 measure optical density changes (O.D.)  1030 . The step 2.03 measure optical density changes (O.D.)  1030  evaluations include 2.04  1040  which are correlated using a 2.041 condition  1050 , 2.041a drug (or combination) produces a change in O.D.&gt;1.0  1052  and 2.042 suggested clinician decision  1060 . For example 2.042a consider using the drug (or combination) to treat patient alone or with other drugs or biological agent  1062 . 2.041b drug (or combination) produces a change in O.D.≤1.0 or no change  1054  and 2.042b consider not using the drug or combination, but instead consider alternative drugs or biological agents  1064  of one embodiment. 
     3.0 Using APOP for Anti-Immunological Therapy: 
       FIG. 11  shows a block diagram of an overview of 3.0 using APOP for anti-immunological therapy of one embodiment.  FIG. 11  shows step 3.0 using APOP for anti-immunological therapy (e.g. for autoimmune diseases, multiple sclerosis, transplant rejection)  1100  using 3.01 immune cells (e.g. lymphocytes, T cells, T cell subsets, NK cells, B cells, monocytes, macrophages, alone or in combination  1110 . The process includes 3.02 APOP assay with drugs, natural products, nutrients and/or cannabinoids, corticosteroids, immune modulators, experimental agents alone or in combination  1120 . This process include 3.03 measure optical density changes (O.D.)  1130  and 3.04 evaluate and suggest decisions as in 2.04  1140  of one embodiment. 
     4.0 Using APOP to Increase Immune Therapy Effects: 
       FIG. 12  shows a block diagram of an overview of 4.0 using APOP to increase immune therapy effects of one embodiment.  FIG. 12  shows step 4.0 using APOP to increase immune therapy effects (e.g. for cancer leukemia or other neoplastic disease)  1200 . 4.01 immunoactive cells (e.g. lymphocytes, lymphoid suppressor cells, lymphocytes with highly active checkpoint inhibitors are purified from patient fluid or biopsies  1210  and as in 3.02 with addition of immunoactive cells  1220 , as in 3.03  1230  and as in 3.04  1240  of one embodiment. 
     5.0 Extended APOP Assay Decision Tree: 
       FIG. 13  shows a block diagram of an overview of 5.0 extended APOP assay decision tree of one embodiment.  FIG. 13  shows 5.0 extended APOP assay decision tree  1300 . The 5.0 extended APOP assay decision tree  1300  includes a correlation of condition  1310 , extension  1320  and suggested clinician decision  1330 . A condition  1310  includes for example APOP assay-cells alone or in combination as in 1.05  1312 , an extension  1320  for example 5.01 add immune cells (as in 3.01 or 4.01 or car-t cells or modified lymphocytes) and target cells and measure O.D.  1322  and suggested clinician decision  1330  for example if drugs alone or in combination plus immune cells increase O.D. change &gt;1 S.D., consider adding those drugs or combinations to other immune therapy (e.g. immune cells, checkpoint inhibitors)  1332 . The 5.0 extended APOP assay decision tree  1300  continues with same  1314 , add immune cells as in 5.01 plus target cells and measure protein release from purified cancer cells, if drugs increase protein release;  1324  and consider adding drugs together with immune cells or immuno-oncologic (IO) drugs to increase immune response or consider giving drugs or combinations first and adding immune cells and/or IO drugs later  1334 . Same  1316  condition  1310 , 5.02 add target cells with inflammatory cells (as in 2.01). If drugs or combinations with added inflammatory cells increase O.D. change &gt;1 S.D. then  1326 , and consider adding drugs or combinations with inflammatory cells  1336 . Same  1318  condition  1310 , if no increase in O.D. change &gt;1 S.D. as in 5.01 or 5.02 then  1328 , consider not adding the drugs or combinations or inflammatory cells or immune cells  1338  of one embodiment. 
     6.0 Pre-APOP Assay Decision Tree: 
       FIG. 14  shows a block diagram of an overview of 6.0 pre-APOP assay decision tree of one embodiment.  FIG. 14  shows step 6.0 pre-APOP assay decision tree  1400  using a cell sample as in 1.02  1402  followed by 1.03  404  and 1.04  1406 . The 6.0 pre-APOP assay decision tree  1400  includes testing  1420  and suggested clinician decision  1430  for the series of testing conditions for example 6.1  1410 , immunohistology (e.g. estrogen receptor progesterone receptor her2 testing)  1421  and if positive use hormone blocker or immunological agent  1431 . 
     Additional testing conditions include 6.2  1412 , fish (e.g. her 2 testing)  1422 , if positive use biological agent  1432 ; 6.3  1414 , immune marker testing (e.g. pdl1 or pd1)  1423 , and if positive use immunological agent  1433 ; 6.4  1416 , flow cytometry (to measure targets or markers)  1424 , and if positive use biological agent  1420 ; 6.5  1418 , next generation sequencing or hot spot sequencing  825 , and if positive use agent targeted to the mutation or over expression or use clinical trial of such a drug  1435 . Additional suggested clinician decision  1430  include at time of progression of cancer leukemia or neoplastic condition  1440 , collect a sample as in 1.02  1450 , purify cells as in 1.03  1460 , and perform APOP assay as in 1.04, 1.05  1470  of one embodiment. 
     7.0 Parallel APOP Assay Decision Tree: 
       FIG. 15  shows a block diagram of an overview of 7.0 parallel APOP assay decision tree of one embodiment.  FIG. 15  shows 7.0 parallel APOP assay decision tree  1500  with steps that include collect a cell sample as in 1.02  1510 , process in 1.02, 1.03, 1.04 and also in parallel test as in 6.1, 6.2, 6.3, 6.4, 6.5  1520 . The 7.0 parallel APOP assay decision tree  1500  correlates the results of APOP  1530 , results of 6.1, 6.2, 6.3, 6.4, or 6.5  1540  and suggested clinician decision  1550  for example negative*  1531  wherein * all results of drugs or combinations give an increase in O.D. change ≤1.0 S.D.  1560 , positive  1541 , and use drugs from 6.1, 6.2, 6.3, 6.4, or 6.5 but not drugs or combinations from APOP and at progression collect another sample as in 1.02 and perform another APOP assay  1551 . Another example for positive +   1532  wherein  +  a drug or combination produces an increase in O.D. change &gt;1.0 S.D.  1570 , positive  1542 , and use drug from APOP assay with drug from 6.1, 6.2, 6.3, 6.4 or 6.5  1552 . 
     Block  1533  and  1534  are empty and reflect the same results of APOP  1530  shown in positive+  1532 , with positive  1543  and or use drug from APOP first and drug from 6.1, 6.2, 6.3, 6.4 or 6.5 at progression  1553 . Continuing with positive  1544 , and or use drug from 6.1, 6.2, 6.3, 6.4 or 6.5 and drug from APOP at progression  1554 . Results of APOP  1530  show positive  1535 , negative  1545  and use drug from APOP and do not use drug from 6.1, 6.2, 6.3, 6.4 or 6.5 and retest for APOP and 6.1, 6.2, 6.3, 6.4 and 6.5 at progression  1555  of one embodiment. 
     8.0 Interpretation of APOP Results for a Series of Drugs or Combinations: 
       FIG. 16  shows a block diagram of an overview of 8.0 interpretation of APOP results for a series of drugs or combinations of one embodiment.  FIG. 16  shows step 8.0 interpretation of APOP results for a series of drugs or combinations  1600 . Step 8.0 interpretation of APOP results for a series of drugs or combinations  1600  includes an analysis of multiple drugs and/or combinations as in 1.0 (including 1.01 to 1.05)  1610  and steps to sort drugs and combinations by activity and create a ladder as drugs by amount of increase in O.D. change  1620 . For example if more than 1 drug or combinations produces an increase in O.D. change &gt;1.0 (e.g. drugs A, B, C, but not drugs X, Y, Z) and are within 1 S.D. of each other  1640  a suggested clinician decision:  1642  includes use the drug/combination A or B or C that has least toxicity or least expense and do not use drug X, Y, or Z  1644 , at progression use another A or B or C at progression not previously used or perform another APOP assay  1646  and at progression use next most active drug or combinations after A or B or C but not X or Y or Z or perform another APOP assay  1648  and continue to  FIG. 17A  of one embodiment. 
     Another example includes only 1 drug or combination produces the highest change in O.D.&gt;1.0 (e.g. drug F) and by more than 1 S.D. and others do not (e.g. drugs P, Q, R)  1630 . A suggested clinician decision:  1632  includes use next most active drug or combination  1634 , at progression  1636  and use next most active use drug or combination after F but not P, Q, R or perform another APOP assay  1638  of one embodiment. 
     9.0 Using the APOP Assay on Therapy of Patients with Resistant or Heavily Pretreated Cancer: 
       FIG. 17A  shows a block diagram of an overview of 9.0 using the APOP assay on therapy of patients with resistant or heavily pretreated cancer of one embodiment.  FIG. 17A  shows a continuation from  FIG. 8  and  FIG. 16  including step 9.0 using the APOP assay on therapy of patients with resistant or heavily pretreated cancer and clinician and/or the patient is considering no further standard chemotherapy  1700 . Step 9.0 using the APOP assay on therapy of patients with resistant or heavily pretreated cancer and clinician and/or the patient is considering no further standard chemotherapy  1700  includes processing with a tumor biopsy as in 1.02 and testing as in 6.1, 6.2, 6.3, 6.4, 6.5  1710  followed by 1.03  404 , 1.04  906 , and 1.05  300 . The steps are further described in  FIG. 17B  of one embodiment. 
     Situations: 
       FIG. 17B  shows a block diagram of an overview of situations of one embodiment.  FIG. 17B  shows a continuation from  FIG. 17A  with situations  1720 . Situations  1720  include APOP assay  1730 , results of 6.1, 6.2, 6.3, 6.4, and 6.5  1740 , and suggestion for clinician decision  1750 . For example APOP assay  1730  includes all drugs increase in O.D. change 1.0  1731 , negative  1741  and consider hospice or supportive/palliative care or clinical trial  1751 . APOP assay  1730  is same  1732  with a positive  1742  results of 6.1, 6.2, 6.3, 6.4, and 6.5  1740  and consider hospice or palliative care or clinical trial or drug from 6.1, 6.2, 6.3, 6.4, 6.5  1752 . The situations  1720  continue with CBD or cannabinoid O.D. change &gt;1.0 but chemo therapy drugs all 1.0  1733 , negative  1743 , and consider CBD or cannabinoid or hospice or palliative care or clinical trial  1753 . A drug (e.g. drug X) gives an O.D. change &gt;1.0  1734 , negative  1744 , consider drug x alone  1754 . Same  1735  APOP assay  1730 , positive  1745 , and consider drug X alone or with drug from 6.1, 6.2, 6.3, 6.4, 6.5  1755 . A drug combination (+/−CBD or cannabinoid gives an O.D. change &gt;1.0 and CBD or cannabinoid O.D. change versus drug or drug combination is &lt;=1.0 S.D.  1736 , negative  1746 , and consider drug combination alone  1756  of one embodiment. The process continues in  FIG. 17C . 
     Situations Continued: 
       FIG. 17C  shows a block diagram of an overview of situations continued of one embodiment.  FIG. 17C  shows a continuation from  FIG. 17B  with situations continued  1722  that include the APOP assay  1730 , the results of 6.1, 6.2, 6.3, 6.4, and 6.5  1740  and the suggestion for clinician decision  1750 . Examples include same  1760 , positive  1770 , and consider drug combination alone or with drug from 6.1, 6.2, 6.3, 6.4, 6.5  1780 . An APOP assay  1730  with drug or combination plus CBD or cannabinoid O.D. change is &gt;1.0 S.D. higher than drug or combination alone  1761 , positive  1771 , and consider drug or combination with CBD or cannabinoid  1781 . Drug or combination plus CBD or cannabinoid O.D. change is &gt;1.0 S.D. higher than drug or combination alone  1762 , negative  1772 , and consider drug or combination with CBD or cannabinoid but not with drug from 6.1, 6.2, 6.3, 6.4, or 6.5  1782  of one embodiment. 
     10.0 Interpretation of APOP Results for Drugs or Combinations Based on Amount of O.D. Change: 
       FIG. 18  shows a block diagram of an overview of 10.0 interpretation of APOP results for drugs or combinations based on amount of O.D. change of one embodiment.  FIG. 18  shows a continuation from  FIG. 8  with step 10.0 interpretation of APOP results for drugs or combinations based on amount of O.D. change  1800  with an analysis of drug or combination as in 1.0 including 1.01 to 1.05  1810 . The analysis of drug or combination as in 1.0 including 1.01 to 1.05  1810  includes APOP change in O.D.  1820  and suggested clinician decision  1830 . For example drug (e.g. drug or combination A) result &gt;5 (“very high positive”)  1821  and strongly consider using drug A alone or in combination (10.01 with hormones, targeted or biological agents or immuneoncology agents or radiation or surgery)  1831 . 
     Drug result &gt;3-5 (“high positive”)  1822  with suggested clinician decision  1830  consider using drug alone or in combination (see 10.01)  1832 . Drug result &gt;1-3 (“low positive”)  1823  and consider using drug alone or in combination (see 10.01)  1833 . Drug result 1.0 (“negative”)  1824  and do not consider using drug alone but consider other therapy (see 10.01)  1834 . No drug or combination gives APOP result &gt;1.0  1825  and consider hospice or palliative care or clinical trial or other non-tested drug or other therapy (see 10.01)  1835  and consider another biopsy and APOP test of another tumor site  1836 . The analysis of drug or combination as in 1.0 including 1.01 to 1.05  1810  includes APOP assay cannot be performed or is not successful  1840  and consider another biopsy and APOP test of another tumor site  1836 . Another situation includes at time of tumor progression  1850  consider another biopsy and APOP test of another tumor site  1836  of one embodiment. 
     11.0 Interpretation of APOP Results for Drugs with Similar Mechanisms of Action: 
       FIG. 19  shows a block diagram of an overview of 11.0 interpretation of APOP results for drugs with similar mechanisms of action of one embodiment.  FIG. 19  shows 11.0 interpretation of APOP results for drugs with similar mechanisms of action (e.g. “alkylating agents” [cyclophosphamide, ifosfamide, bendamustine] or “platinum” drugs [cisplatin, carboplatin, oxaliplatin] or “tubulin inhibitors” [paclitaxel, docetaxel, nab-paclitaxel])  1900  and includes an analysis of drugs or combinations as in 1.0 (including 1.01 to 1.05)  1910 . The analysis of drugs or combinations as in 1.0 (including 1.01 to 1.05)  1910  is correlated in result APOP change in O.D.  1920 , interpretation  1930 , and suggested clinician decision  1940  categories. For example drug A and drug B O.D. changes &gt;1.0 and drug A O.D. change &gt;1 S.D. higher than drug B  1921  with the interpretation  1930  drug A is superior to drug B  1931 , and consider using drug A initially, can consider using drug B at progression  1941 . 
     Drug A and drug B O.D. changes &gt;1.0 and O.D. changes are within 1 S.D. of each other  1922 , drug A and drug B are equal  1932 , and consider using drug A or drug B based on expected toxicity or cost; can consider using other drug B or A at progression  1942 . Drug A O.D. change is &gt;1.0 and drug B change is &lt;1.0  1923 , drug A is effective and drug B is ineffective  1933 , consider using drug A and not using drug B  1943 , and at progression consider other therapy (as in 6.1, 6.2, 6.3, 6.4 or 6.5) or repeat APOP assay  1944 . Drug A and drug B O.D. changes are &lt;1.0  1924 , neither drug A nor drug B is effective  1934 , and consider using other therapy (as in 6.1, 6.2, 6.3, 6.4 or 6.5) or repeat APOP assay  1945  of one embodiment. 
     12.0 Advanced Interpretation of APOP Results Using O.D. Change and Maximum O.D. Increase from a Single Drug or Combination: 
       FIG. 20  shows a block diagram of an overview of 12.0 advanced interpretation of APOP results using O.D. change and maximum O.D. increase from a single drug or combination of one embodiment.  FIG. 20  shows step 12.0 advanced interpretation of APOP results using O.D. change and maximum O.D. increase from a single drug or combination  2000  including an analysis of drugs or combinations as in 1.0 (including 1.01 to 1.05)  2010 . The analysis of drugs or combinations as in 1.0 (including 1.01 to 1.05)  2010  a rate of change in O.D.  2020 , maximum increase in O.D. units  2030 , interpretation of anticellular* effect  2040  wherein *anticellular may mean antitumor, anti-leukemia, anti-lymphoid, anti-inflammatory effect  2041 , and suggested clinician decision  2050  of one embodiment. 
     The rate of change in O.D.  2020  includes for example at least four rates of change in O.D. ratings including a high  2022 , intermediate  2024 , low  2026  and no change  2028 . The high  2022 , intermediate  2024 , low  2026  rates each include a subset of rates for high, intermediate, and low. For example rate of change in O.D.  2020  high  2022 , high  2031 , high effect 80  2060 ; intermediate  2032 , high effect 80  2061 , and low  2033 , high effect 60  2062  with suggested clinician decision  2050  consider using the drug or combination with highest anti-cellular effect  2051  of one embodiment. 
     Rate of change in O.D.  2020  intermediate  2024 , high  2031 , high effect 80  2063 ; intermediate  2032 , intermediate effect 60  2064 ; low  2033 , low effect 40  2065  and consider using the drug or combination with highest anti-cellular effect  2051  of one embodiment. 
     Rate of change in O.D.  2020  low  2026 , high  2031 , low effect 40  2066 ; intermediate  2032 , very low effect 20  2067 ; low  2033 , very low effect 10  2068  and consider using the drug or combination with highest anti-cellular effect  2051  of one embodiment. 
     Rate of change in O.D.  2020  no change  2028 , any  2035 , no effect drugs inactive  2069  and consider using another therapy but not the drugs or combination  2052  of one embodiment. 
     13.0 Enhancing Drug Development Decisions by Use of APOP Assay and Cell Growth Inhibition: 
       FIG. 21  shows a block diagram of an overview of 13.0 enhancing drug development decisions by use of APOP assay and cell growth inhibition of one embodiment.  FIG. 21  shows 13.0 enhancing drug development decisions by use of APOP assay and cell growth inhibition  2100  with established cancer cell lines plus drug  2110 . The 13.0 enhancing drug development decisions by use of APOP assay and cell growth inhibition  2100  combines processes to measure APOP assay O.D. changes  2120  and measure inhibition of cell growth  2124 . Should the measurements show both tests are negative  2134  then add drug to other agents in combinations  2136  of one embodiment. 
     When either test is positive  2130  proceed with short term purified cancer cells in culture (as in  FIG. 2 )  2140 . Measure APOP assay O.D. change  2142  and measure inhibition of cell growth  2144  and if both tests are negative  2145  add drug together with other agents in combinations  2147 . If either test is positive  2143  direct APOP assay of purified cells (as in 1.0 (including 1.01 to 1.05)  2150 . If positive results  2152  then suggest clinical trial of best drug or drug combination in the diseases from which the purified cells show a positive result and avoid trials in diseases from which purified cells show negative results  2154 . If negative results  2160  then add drug together with other agents  2162  of one embodiment. 
     14.0 a Method to Reduce Cost of Chemotherapy and/or Drug Therapy for Cancer: 
       FIG. 22  shows a block diagram of an overview of 14.0 a method to reduce cost of chemotherapy and/or drug therapy for cancer of one embodiment.  FIG. 22  shows step 14.0 a method to reduce cost of chemotherapy and/or drug therapy for cancer  2200 . The 14.0 method to reduce cost of chemotherapy and/or drug therapy for cancer  2200  includes a cell sample as in 1.02  2210  and processing to prepare as in 1.03, 1.04  2220 . The processing to prepare as in 1.03, 1.04  2220  includes cells alone  2230 , cells plus expensive single source or multiple single source drug  2231 , cells plus inexpensive drugs multiple source or inexpensive generic or single source drugs  2232 , cells plus combinations of expensive drugs  2233 , cells plus combinations of inexpensive drugs  2234 , cells plus inexpensive single drugs+CBD+/−THC  2235 , and cells plus inexpensive drug combinations+CBD+/−THC  2236 . 
     The 14.0 method to reduce cost of chemotherapy and/or drug therapy for cancer  2200  includes a process to identify most effective therapies as in 8.0 and 10.0  2240  and a process to evaluate cost of most effective therapies  2250 . 
     The process to evaluate cost of most effective therapies  2250  is significant as health plan or hospital or network considers using least expensive of the most effective therapies  2260 , physician or practice considers using least expensive of the most effective therapies  2262 , patient considers using the least expensive of the most effective therapies  2264 , and state or federal government or governmental agency considers using the least expensive of the most effective therapies  2266  of one embodiment. Additional descriptions continue in  FIG. 23 . 
     Cost of Drugs or Therapies Defined: 
       FIG. 23  shows a block diagram of an overview of cost of drugs or therapies defined of one embodiment.  FIG. 23  shows continuing from  FIG. 22  that cost of drugs or therapies may be defined as  2300 , average sales price  2310 , average wholesale price  2320 , acquisition price  2330 , net cost to health plan or network or physician office (after discounts or rebates or other incentives)  2340 , net cost to patient  2350 , net cost to hospital  2360 , and patient copay  2370  of one embodiment. 
     15.0 a Method to Promote Immune Therapy Effects of Immuno-Active Drugs and/or Immune Cells in Treating Cancer or Leukemia: 
       FIG. 24A  shows a block diagram of an overview of 15.0 a method to promote immune therapy effects of immuno-active drugs and/or immune cells in treating cancer or leukemia of one embodiment.  FIG. 24A  shows step 15.0 a method to promote immune therapy effects of immuno-active drugs and/or immune cells in treating cancer or leukemia  2400 . The process includes 15.01 blood samples from a patient with cancer or leukemia  2410 . A process to isolate or purify immune cells +  (as in 3.01)  2420  where  +  immune cells=cells as in 3.01  2425 . Processing continues with 15.02 preincubation with immuno-active drugs (e.g. PD1 or PDL1 or CTLA4 inhibitors alone or in combination with other immuno-active agents)  2430  and use as immune-active cell source in  FIG. 12  (4.0) and in  FIG. 26  (15.2)  2434 . Including a process for 15.03 immune cells without preincubation with chemotherapy or antineoplastic drug  2432  and use as immuno-active cell source in  FIG. 12  (4.0) and in  FIG. 26  (15.2)  2434  of one embodiment. 
     15.1 Cancer or Leukemia Cells: 
       FIG. 24B  shows a block diagram of an overview of 15.1 cancer or leukemia cells of one embodiment.  FIG. 24B  shows step 15.1 cancer or leukemia cells as in 1.01, 1.02, 1.03, 1.04  2440 . The process with 15.1 cancer or leukemia cells as in 1.01, 1.02, 1.03, 1.04  2440  further continues in  FIG. 25 . The process with 15.1 cancer or leukemia cells as in 1.01, 1.02, 1.03, 1.04  2440  includes an APOP assay as in 1.04, 1.05  2441 . The APOP assay as in 1.04, 1.05  2441  includes a process to measure molecule* release into supernatant culture fluid  2442  where * molecule &gt;e.g. protein, antigen, cell component  2444 . A high release  2450  prompts to consider using chemotherapy drugs to increase molecule presentation and immune response  2451  including drugs before immunotherapy  2452 , drugs together with immunotherapy  2453 , and drugs alternating with immunotherapy  2454 . A low release and low change in O.D.  2460  prompts to consider using immunotherapy alone  2462  wherein a progression of cancer  2464  leads to repeat APOP assay as in 15.1 or 1.02-1.05  2466  of one embodiment. 
     16.0 a Method to Evaluate Whether to Consider Using Immunoactive Drugs to Treat Cancer: 
       FIG. 24C  shows a block diagram of an overview of 16.0 a method to evaluate whether to consider using immunoactive drugs to treat cancer of one embodiment.  FIG. 24C  shows a method to evaluate whether to consider using immunoactive drugs to treat cancer  2470 . The method to evaluate whether to consider using immunoactive drugs to treat cancer  2470  includes step 15.02 APOP assay  2471  and if APOP assay 15.02 change in O.D. is &gt;=1 S.D. higher than 15.03  2472  then consider using the immunoactive drugs alone or in combination with other immunoactive agents or  2473  of one embodiment. 
     The 15.02 APOP assay  2471  is also performed in in step 15.03 with chemotherapy or antineoplastic drug  2474 , if 15.02 change is less than 1 S.D. higher than 15.03  2475  then consider not using the immunoactive drugs alone or in combination with other immunoactive agents and consider using chemotherapy or antineoplastic drugs alone  2476  of one embodiment. 
     Measure Immune Marker Before APOP Assay: 
       FIG. 25  shows a block diagram of an overview of measure immune marker before APOP assay of one embodiment.  FIG. 25  shows a continuation from  FIG. 24B  from step 15.1 cancer or leukemia cells as in 1.01, 1.02, 1.03, 1.04  2440  of  FIG. 24B  with a process to measure immune marker (e.g. PDL1) before APOP assay  2500 . The process includes performing an APOP assay as in 1.04-1.05  2510 . A process in the APOP assay as in 1.04-1.05  2510  will measure immune marker in cancer cells remaining after APOP assay  2520 . 
     If no increase in immune marker  2521  then consider using chemotherapy only  2522  and at progression repeat 15.1  2523 . This process continues in  FIG. 26  of one embodiment. 
     If there is an increase immune marker  2530  consider chemotherapy and then immunotherapy drug active against immune marker  2540  then proceed to the processes in  FIG. 26  of one embodiment. 
     If there is an increase in immune markers  2530  consider using chemotherapy with immunotherapy drug active against immune marker  2550  then proceed to the processes in  FIG. 26  of one embodiment. 
     If there is an increase immune marker  2530  consider using chemotherapy alternating with immunotherapy drug active against the immune marker  2560  then proceed to the processes in  FIG. 26  of one embodiment. If drugs are alleged before testing to be biosimilar or identical but testing with APOP or other tests are found not to be equivalent, then neither drug may be sold as biosimilar or equivalent; this may help extend marketing of the original drug and force a putative biosimilar to undergo further testing and not be marketed. 
     15.2 APOP Assay Cancer Cells: 
       FIG. 26  shows a block diagram of an overview of 15.2 APOP assay cancer cells of one embodiment.  FIG. 26  shows a continuation from  FIG. 25  with step 15.2  2600 . Step 15.2  2600  includes 15.21 APOP assay cancer cells alone as in 1.05  2602  and 15.22 APOP assay with cancer cells alone and chemotherapy drugs  2604 . Step 15.2  2600  also includes an APOP assay cancer cells+preincubated immune cells from 15.02  2606  where with O.D. change higher than 15.21  2610  consider using immune cells preincubated with active drug  2612  and consider using immuno-active drug alone  2614  of one embodiment. 
     An APOP assay cancer cells+preincubated immune cells from 15.02  2606  where an O.D. change is higher than 15.21 and 15.22 is high  2620  consider using immune cells preincubated plus chemotherapy  2622  or consider using immuno-active drug plus chemo therapy (together or sequential or alternating)  2624  of one embodiment. 
     An APOP assay cancer cells+preincubated immune cells from 15.02  2606  with an O.D. change not higher than 15.21 and 15.22 is greater than 15.21  2630  consider not using pre-incubated immune cells and consider not using immune-active drug alone  2632  and consider using chemotherapy alone  2634  and at progression consider repeat APOP as in 15.1 or 1.02-1.05  2636  of one embodiment. 
     An APOP assay cancer cells+immune cells not pre-incubated from 15.03  2608  where an O.D. change is higher than 15.21  2640  consider using immune cells alone or with chemotherapy if 15.22 is high  2642  and at progression consider repeat APOP assay as in 15.1 or 1.02-1.05  2644  of one embodiment. 
     In the APOP assay cancer cells+immune cells not pre-incubated from 15.03  2608  where an O.D. change is not higher than 15.21 and 15.22 is higher than 15.21  2650  consider using chemotherapy alone  2652  and at progression consider repeat APOP as in 15.1 or 1.02-1.05  2654  of one embodiment. 
     17.0 a Method to Identify Non-Equivalences of Drugs: 
       FIG. 27A  shows a block diagram of an overview of 17.0 a method to identify non-equivalences of drugs of one embodiment.  FIG. 27A  shows step 17.0 a method to identify non-equivalences of drugs  2700 . Step 17.0 a method to identify non-equivalences of drugs  2700  is a process where two or more drugs are compared in the APOP or other assays to determine if they are equivalent or biosimilar  2710 . If drugs are alleged before testing to be biosimilar or identical but testing with APOP or other tests are found not to be equivalent, then neither drug may be sold as biosimilar or equivalent; this may help extend marketing of the original drug and force a putative biosimilar to undergo further testing and not be marketed. This may identify other comparable drugs that may have equal or greater effectiveness and may be able to reduce cost with their use of one embodiment. 
     17.1 Using the APOP Assay: 
       FIG. 27B  shows a block diagram of an overview of 17.1 using the APOP assay of one embodiment.  FIG. 27B  shows step 17.1 using the APOP assay  2720  where cancer cells are purified (from cancer patients as in 1.02, 1.03 or from long term cancer cell lines as in 13.0 or from cancer patient short term cell lines as in 1.11)  2730 . Cells are tested in the APOP assay with 2 or more drugs (e.g. drug A which may be proprietary and drug B which may be the same structural or biosimilar drug which is generic  2740  of one embodiment. 
     The testing includes cells alone  2750  with O.D. 17.11  2760 ; cells+drug A  2752  with O.D. 17.12  2762 ; cells+drug B  2754  with O.D. 17.13  2764 ; cells with another drug known to produce Apoptosis+drug A  2756  with O.D. 17.14  2766 ; and cells with another drug known to produce Apoptosis+drug B  2758  with O.D. 17.15  2768 . If 17.12 differs from 17.13 by more than a defined amount (e.g. 1 S.D.) then the drugs are not equivalent  2770 . If 17.14 differs from 17.15 by more than a defined amount (e.g. 1 S.D.) then the drugs are not equivalent  2780  of one embodiment. 
     Cancer cells are purified (from cancer patients as in 1.02, 1.03 or from long term cancer cell lines as in 13.0 or from cancer patient short term cell lines as in 1.11) 2730 then 17.2 cells are tested in culture for inhibition of growth rate in vitro as in 17.11, 17.12, 17.13, 17.15  2732 . Testing results reach same conclusions as in  2734 , if 17.12 differs from 17.13 by more than a defined amount (e.g. 1 S.D.) then the drugs are not equivalent  2770  and if 17.14 differs from 17.15 by more than a defined amount (e.g. 1 S.D.) then the drugs are not equivalent  2780  of one embodiment. 
     18.0 a Method for Identifying an Anti-Apoptosis Drug: 
       FIG. 28  shows a block diagram of an overview of 18.0 a method for identifying an anti-Apoptosis drug of one embodiment.  FIG. 28  shows step 18.0 a method for identifying an anti-Apoptosis drug  2800 . This determines if a drug decreases, inhibits, delays or prevents Apoptosis (e.g., to prevent or delay Alzheimer&#39;s disease, Parkinson&#39;s disease, aging, degenerative disease, cancer, Neoplastic disease or others)  2810 . 
     The 18.0 a method for identifying an anti-Apoptosis drug  2800  uses long term cell line or cells from a patient or short term cell lines from a patient  2820  and perform an APOP assay with an agent known to produce Apoptosis with or without a drug to be tested (e.g. drug X)  2825 . The APOP assay with an agent known to produce Apoptosis with or without a drug to be tested (e.g. drug X)  2825  includes cells alone  2830  with 18.11 O.D.  2840 ; cells+Apoptosis inducing agent  2832  with 18.12 O.D.  2842 ; cells+Apoptosis inducing agent+drug X  2834  with 18.13 O.D.  2844 ; and cells+drug X  2836  with 18.14 O.D.  2846 . If 18.13 is less than 18.12 by some amount (e.g. over 1 S.D.) then drug X is an anti-Apoptosis drug  2850  of one embodiment. 
     Direct APOP Assay of Purified Cells Application: 
       FIG. 29  shows for illustrative purposes only an example of direct APOP assay of purified cells application of one embodiment.  FIG. 29  shows a direct APOP assay of purified cells application  2957  used in processing direct APOP assay results. A patient  2900  visits a doctor&#39;s office/hospital/laboratory  2910  to provide a biopsy tissue sample for determination of a diagnosis and treatment plan  2920 . The patient&#39;s biopsy tissue sample  2920  is conveyed for assaying APOP of purified cells  2930 . Results of APOP  2932 , testing results  2934  and suggested clinician decision  2936  are transmitted to a direct APOP assay network  2950  to record, perform APOP assay, testing results and suggested clinician decision correlation matrix  2940 . 
     The direct APOP assay network  2950  is used for controlling at least one cell purification device for purifying tissue sample cells and for example long term cancer cell lines. The direct APOP assay network  2950  is used for controlling at least one next-generation sequencer device used in performing direct APOP assay of purified cells testing. Receiving and processing tissue samples, processing using at least one cell purification device and testing using at least one next-generation sequencer device or not includes using at least one sterile enclosure of one embodiment. 
     The direct APOP assay network  2950  includes a plurality of digital servers  2952 , a plurality of digital databases  2954 , at least one computer  2956 , at least one digital processor, at least one communication device with internet connectivity (not shown)  2958 , at least one communication device with cellular connectivity (not shown) and at least one printer. The at least one digital processor correlates the APOP assay, testing results and suggested clinician decision data into a predetermined format including a matrix. Predetermined formats include electronic and digital formats for transmission to doctor&#39;s office/hospital/laboratory  2910  using different operating systems and computing languages and display formats. The direct APOP assay of purified cells application  2957  is configured in one embodiment to transmit the predetermined formats using internet transmission of direct APOP assay  2958  to doctor&#39;s office/hospital/laboratory  2910  computers. In another embodiment the direct APOP assay of purified cells application  2957  is configured for communicating and transmitting over cellular smart phone communication  2960  with a cellular tower  2962  to doctor&#39;s digital devices with direct APOP assay of purified cells application  2970 . Doctor&#39;s digital devices including a smart cell phone  2972 , a digital tablet  2974  and a laptop computer  2976  may each have a different operating system. The direct APOP assay of purified cells application  2957  is configured to operate with various operating systems of one embodiment. 
     The foregoing has described the principles, embodiments and modes of operation of the present invention. However, the invention should not be construed as being limited to the particular embodiments discussed. The above described embodiments should be regarded as illustrative rather than restrictive, and it should be appreciated that variations may be made in those embodiments by workers skilled in the art without departing from the scope of the present invention as defined by the following claims.