Method, Array and Use for Determining the Presence of Pancreatic Cancer

Abstract

The present invention relates to a method for determining the presence of pancreatic cancer in an individual comprising or consisting of the steps of: (a) providing a sample to be tested from the individual, and (b) determining a biomarker signature of the test sample by measuring the expression in the test sample of one or more biomarkers selected from the group defined in Table III, wherein the expression in the test sample of one or more biomarkers selected from the group defined in Table III is indicative of the individual having pancreatic cancer. The invention also comprises arrays and kits of parts for use in the method of the invention.

1 . A method for determining the presence of pancreatic cancer in an individual comprising the steps of:
 a) providing a sample to be tested from the individual; and   b) determining a biomarker signature of the test sample by measuring the expression in the test sample of one or more biomarkers selected from the group defined in Table III;   wherein the expression in the test sample of one or more biomarkers selected from the group defined in Table III is indicative of the individual having pancreatic cancer; and   wherein step (b) comprises measuring the expression of one or more of the biomarkers listed in Table IV(A) and/or Table IV(B).   
     
     
         2 - 6 . (canceled) 
     
     
         7 . The method according to  claim 1 , wherein step (b) comprises measuring the expression of 1 or more of the biomarkers listed in Table IV(B). 
     
     
         8 . (canceled) 
     
     
         9 . The method according to  claim 1 , wherein step (b) comprises measuring the expression of 1 or more biomarkers from the biomarkers listed in Table IV(C). 
     
     
         10 . (canceled) 
     
     
         11 . (canceled) 
     
     
         12 . The method according to  claim 1 , wherein the method is for differentiating between pancreatic cancer (PaC) and any other disease state or states. 
     
     
         13 . The method according to  claim 12 , wherein step (b) comprises measuring the expression in the test sample of 1 or more biomarkers from the biomarkers listed in Table V(A). 
     
     
         14 . The method according to  claim 12 , wherein step (b) comprises measuring the expression in the test sample of 1 or more biomarkers from the biomarkers listed in Table V(B). 
     
     
         15 - 18 . (canceled) 
     
     
         19 . The method according to  claim 12 , wherein the other disease state or states is chronic pancreatitis (ChP), acute inflammatory pancreatitis (AIP) and/or normal. 
     
     
         20 - 31 . (canceled) 
     
     
         32 . The method according to  claim 1 , wherein the method is for differentiating between pancreatic cancer and normal individuals (N). 
     
     
         33 - 45 . (canceled) 
     
     
         46 . The method according to  claim 1 , wherein the pancreatic cancer is an adenocarcinoma. 
     
     
         47 . The method according to  claim 1 , wherein step (b) is performed using a first binding agent capable of binding to the one or more biomarkers. 
     
     
         48 . The method according to  claim 47  wherein the first binding agent comprises or consists of an antibody or an antigen-binding fragment thereof. 
     
     
         49 . (canceled) 
     
     
         50 . (canceled) 
     
     
         51 . The method according to  claim 48 , wherein the first binding agent is immobilised on a surface. 
     
     
         52 . The method according to  claim 1 , wherein the one or more biomarkers in the test sample are labelled with a detectable moiety. 
     
     
         53 - 62 . (canceled) 
     
     
         63 . The method according to  claim 1 , wherein step (b) is performed using an array. 
     
     
         64 . (canceled) 
     
     
         65 . The method according to  claim 63  wherein the array is a surface-based array. 
     
     
         66 . (canceled) 
     
     
         67 . The method according to  claim 1 , wherein the method comprises:
 (i) labelling biomarkers present in the sample with biotin;   (ii) contacting the biotin-labelled proteins with an array comprising a plurality of scFv immobilised at discrete locations on its surface, the scFv having specificity for one or more of the proteins in Table III;   (iii) contacting the immobilised scFv with a streptavidin conjugate comprising a fluorescent dye; and   (iv) detecting the presence of the dye at discrete locations on the array surface;   wherein the expression of the dye on the array surface is indicative of the expression of a biomarker from Table III in the sample.   
     
     
         68 - 83 . (canceled) 
     
     
         84 . The method according to  claim 1 , wherein the sample provided in step (b) is selected from the group consisting of unfractionated blood, plasma, serum, tissue fluid, pancreatic tissue, pancreatic juice, bile and urine. 
     
     
         85 . The method according to claim  84 , wherein the sample provided in step (b) is selected from the group consisting of unfractionated blood, plasma and serum. 
     
     
         86 . (canceled) 
     
     
         87 . An array for determining the presence of pancreatic cancer in an individual comprising one or more binding agent as defined in  claim 47 . 
     
     
         88 . An array according to  claim 87  wherein the one or more binding agents is capable of binding to all of the proteins defined in Table III. 
     
     
         89 - 94 . (canceled)