Diagnostic for colorectal cancer

Abstract

The present invention provides a method for diagnosing or detecting colorectal cancer in a subject, the method comprising determining the presence and/or level of biomarkers selected from IL-8, IGFBP2, MAC2BP, M2PK, IL-13, DKK-3, EpCam, MIP1β, TGFβ1, and TIMP-1. The invention also relates to diagnostic kits comprising reagents for determining the presence and/or level of the biomarkers and methods of detecting or diagnosing colorectal cancer.

1 . A method for diagnosing or detecting colorectal cancer in a subject, the method comprising:
 i) determining the presence and/or level of at least two biomarkers selected from the group consisting of IL-8, IGFBP2, MAC2BP, M2PK, IL-13, DKK-3, EpCam, MIP1β, TGFβ1, and TIMP-1 in a sample from the subject,   wherein the presence and/or level of the two biomarkers is indicative of colorectal cancer.   
     
     
         2 . The method of  claim 1 , wherein the two biomarkers selected from M2PK, EpCam, IL-13, DKK-3, IL-8 and IGFBP2. 
     
     
         3 . The method of  claim 1 , wherein the method comprises determining the presence and/or level of expression of at least three of the biomarkers. 
     
     
         4 . The method of  claim 3 , wherein the three biomarkers are selected from the group consisting of M2PK, EpCam, IL-13, DKK-3, IL-8, IGFBP2, MIP1β, TGFβ1 and MAC2BP. 
     
     
         5 . The method of  claim 4 , wherein the three biomarkers are as follows:
 i) DKK-3, M2PK, and IGFBP2;   ii) M2PK, IGFBP2, and EpCAM;   iii) M2PK, MIP1β, and TGFβ1; or   iv) IL-8, IL-13, and MAC2BP.   
     
     
         6 . The method of  claim 1 , wherein the method comprises determining the presence and/or level of expression of at least four of the biomarkers. 
     
     
         7 . The method of  claim 6 , wherein four biomarkers are as follows:
 i) DKK-3, M2PK, MAC2BP, and IGFBP2;   ii) IL-8, IL-13, MAC2BP, and EpCam;   iii) DKK3, M2PK, TGFβ1, and TIMP-1;   iv) M2PK, MIP1β, IL-13, and TIMP-1; or   v) IL-8, MAC2BP, IGFBP2, and EpCam.   
     
     
         8 . The method of  claim 1 , wherein the method comprises determining the presence and/or level of at least five of the biomarkers. 
     
     
         9 . The method of  claim 1 , wherein the method comprises determining the presence and/or level of at least six of the biomarkers. 
     
     
         10 . The method of  claim 1 , wherein the method comprises determining the presence and/or level of at least seven of the biomarkers. 
     
     
         11 . The method of  claim 1 , wherein the method comprises determining the presence and/or level of at least eight of the biomarkers. 
     
     
         12 . The method of  claim 1 , wherein the method comprises determining the presence and or level of at least nine of the biomarkers. 
     
     
         13 . The method of  claim 1 , wherein the method comprises determining the presence and/or level of at least ten of the biomarkers. 
     
     
         14 . The method of  claim 1 , wherein the method comprises detecting the presence and/or level of least one additional biomarker selected from the group consisting of ICF-I, IGF-II, IGF-BP2, Amphiregulin, VEGFA, VEGFD, MMP-1, MMP-2, MMP-3, MMP-7, MMP-9, TIMP-1, TIMP-2, ENA-78, MCP-1, MIP-1β, IFN-γ, IL-10, IL-13, IL-1β, IL-4, IL-8, IL-6, MAC2BP, Tumor M2 pyruvate kinase, M65, OPN, DKK-3, EpCam, TGFβ-1, and VEGFpan. 
     
     
         15 . The method of  claim 1 , wherein the method diagnoses or detects colorectal cancer with a sensitivity of at least 50%. 
     
     
         16 . (canceled) 
     
     
         17 . (canceled) 
     
     
         18 . The method of  claim 1 , wherein the method diagnoses or detects Dukes Stage A colorectal cancer with a sensitivity of at least 50% and a specificity of at least 95%; a sensitivity of at least 60% and a specificity of at least 80%; or a sensitivity of at least 50% and a specificity of at least 90%. 
     
     
         19 . (canceled) 
     
     
         20 . (canceled) 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . (canceled) 
     
     
         24 . (canceled) 
     
     
         25 . (canceled) 
     
     
         26 . The method of  claim 1 , wherein the method comprises:
 i) determining the presence and/or level of the biomarkers in the sample from the subject; and   ii) comparing the presence and/or level of the biomarkers relative to a control, wherein a presence and/or level in the sample that is different to the control is indicative of colorectal cancer.   
     
     
         27 . The method of  claim 1 , wherein the sample comprises blood, plasma, serum, urine, platelets, magakaryocytes or faeces. 
     
     
         28 . A method of treatment comprising:
 (i) diagnosing or detecting colorectal cancer according to the method of  claim 1 ; and   (ii) administering a therapeutic suitable for the treatment of colorectal cancer.   
     
     
         29 . A method for monitoring the efficacy of treatment of colorectal cancer in a subject, the method comprising treating the subject for colorectal cancer and then detecting the presence and/or level of at least two biomarkers selected from IL-8, IGFBP2, MAC2BP, M2PK, IL-13, DKK-3, EpCam, MIP1β, TGFβ1, and TIMP-1 in a sample from the subject, wherein an absence of and/or reduction in the level of expression of the biomarkers after treatment as compared with before treatment is indicative of an effective treatment. 
     
     
         30 . (canceled) 
     
     
         31 . (canceled)