Patent ID: 8772038
Filing Date: 2014-07-08
Classification: G01N,Y10T

Abstract:
1. A method for determining an increased risk of developing a breast tumor in a test subject, the method comprising: (a) obtaining from the test subject a saliva sample and detecting at least a first protein biomarker in said sample, wherein said protein biomarker is selected from the group consisting of CAH6 (Carbonic anhydrase VI), K2C4 (Cytokeratin 4), CYTA (Cystatin A), FABP4 (Epid. Fatty acid binding prot.), IGHGI (Ig gamma-1 chain C region), TRFL (Lactoferrin), BPIL1 (Bact. Perm.-increasing prot.-1), CYTC (Cystatin C), HPT (Haptoglobin), PROF1 (Profilin-1), ZA2G (Zinc-alpha-2-glycoprotein), ENOA (A1pha enolase), IGHA2 (Ig alpha-2 chain C region), IL-1 ra (Interleukin-1 receptor anatagonist protein precursor), S10A7 (S100 calcium-binding protein A7), and SPLC2 (Short palate, lung and nasel epith Carc. assoc. protein 2), and wherein the protein biomarker is detected and characterized by transforming the first protein biomarker in the test sample by: (a′) measuring a concentration of said protein biomarker to provide a set of test data comprising a test concentration value of each protein biomarker in said saliva sample; (b) comparing said test concentration values from said test subject to a reference panel comprising (c) determining from said comparison of said concentration values an increased risk of developing a breast tumor in the test subject by determining whether the test concentration values of each protein biomarker in the saliva sample from the test subject are significantly the same as or different from the mean concentration values for each said protein biomarker in the reference control group, the reference DCIS group or the reference benign group, wherein the concentration value of at least said first protein biomarker in said reference panel is significantly different in the saliva of said reference DCIS group and/or in the saliva of said reference benign group, relative to the respective concentration value of at least said first protein biomarker in the saliva of said reference control group, wherein the concentration values are significantly different at a level in the range of p<0.05 to p<0.0001.