Biomarker Panel For Diagnosing Cancer

Abstract

The present invention pertains to a new method for the diagnosis, prognosis, stratification and/or monitoring of a therapy, of cancer in a patient. The method is based on the determination of the level of a panel of biomarkers selected from CEA, AREG, IL-6, GDF-15, HGF-receptor, CXCL9, ErbB4-Her4, CXCL10, Flt3L, VEGFR-2, CD69, CXCL5, PSA, EMMPRIN, Cathepsin-D, Caspase-3, TNF-alpha, and INF-gamma. The new biomarker panel of the invention allows diagnosing and even stratifying various cancer diseases. Furthermore provided are diagnostic kits for performing the non-invasive methods of the invention.

1 . A non-invasive method for the diagnosis, prognosis, stratification and/or monitoring of a therapy, of a cancer disease in a subject, comprising the steps of:
 (a) Providing a biological sample from the subject,   (b) Determining the level of at least two or more biomarker selected from the group consisting of Flt3L AREG, CEA, IL-6, GDF-15, HGF-receptor, CXCL9, ErbB4-Her4, CXCL10, VEGFR-2, CD69, CXCL5, PSA, EMMPRIN, Cathepsin-D, Caspase-3, TNF-alpha, and INF-gamma, in the biological sample,   wherein a differential level of the at least two or more biomarkers in the biological sample from the subject as determined in step (b) compared to a healthy control or a reference value is indicative for the presence of a cancer disease in the subject.   
     
     
         2 . The method according to  claim 1 , wherein step (b) comprises determining the level of at least Flt3L or AREG in the biological sample. 
     
     
         3 . The non-invasive method according to  claim 1 , wherein step (b) comprises determining the level of the Flt3L or AREG, in the biological sample. 
     
     
         4 . The method according to  claim 1 , wherein the biological sample is a tissue sample or body liquid sample, preferably a blood sample, most preferably a plasma sample. 
     
     
         5 . The method according to  claim 1 , wherein the biomarker is a protein biomarker. 
     
     
         6 . The method according to  claim 1 , wherein the method is a screening method for establishing a first diagnosis of cancer in the subject. 
     
     
         7 . The method according to  claim 1 , wherein the cancer is colorectal cancer, pancreatic cancer, gastric cancer, breast cancer, lung cancer, prostate cancer, hepatocellular cancer, cervical cancer, ovarian cancer, liver cancer, bladder cancer, cancer of the urinary tract, thyroid cancer, renal cancer, carcinoma, melanoma, leukemia or brain cancer. 
     
     
         8 . The method according to  claim 7 , wherein the cancer is colorectal cancer, gastric cancer or pancreatic cancer. 
     
     
         9 . The method according to  claim 1 , wherein a differential level of a biomarker selected from CEA, GDF-15, AREG, IL-6, CXCL10, CXCL9, PSA, TNF-alpha, and Cathepsin-D, is a level higher than the healthy control or the reference value. 
     
     
         10 . The method according to  claim 1 , wherein a differential level of a biomarker selected from HGF-receptor, ErbB4-Heer4, CXCL5, Flt3L, EMMPRIN, VEGFR-2, CD69 and Caspase-3, is a level lower than the healthy control or the reference value. 
     
     
         11 . The method according to  claim 1 , wherein the biomarker is detected using one or more antibodies, preferably wherein the biomarker is detected by western blot, ELISA, Proximity Extension Assay, or mass-spectrometrically. 
     
     
         12 . The A diagnostic kit for performing a method according to  claim 1 . 
     
     
         13 . The diagnostic kit of  claim 12 , comprising one or more antibodies for the detection of the biomarkers Flt3L and AREG.