Use of biomarkers for detecting ovarian cancer

Abstract

The present invention relates to a method of qualifying ovarian cancer status in a subject comprising: (a) measuring at least one biomarker in a sample from the subject and (b) correlating the measurement with ovarian cancer status. The invention further relates to kits for qualifying ovarian cancer status in a subject.

1 . A method of qualifying ovarian cancer status in a subject comprising:
 (a) measuring at least one biomarker in a sample from the subject, wherein the biomarker is selected from the group consisting of ApoA1, transthyretin ΔN10, IAIH4 fragment, and combinations thereof, and   (b) correlating the measurement with ovarian cancer status.   
     
     
         2 . The method of  claim 1  further comprising:
 (c) managing subject treatment based on the status. 
 
     
     
         3 . (canceled) 
     
     
         4 . The method of  claim 2  further comprising:
 (d) measuring the at least one biomarker after subject management. 
 
     
     
         5 . The method of  claim 1  wherein the ovarian cancer status is selected from the group consisting of the subject's risk of cancer, the presence or absence of disease, the stage of disease and the effectiveness of treatment of disease. 
     
     
         6 . (canceled) 
     
     
         7 . The method of  claim 1  further comprising measuring at least one known biomarker (Marker 4) in a sample from the subject and correlating measurement of the known biomarker and the measurement of ApoA1, transthyretin ΔN10 or IAIH4 fragment with ovarian cancer status. 
     
     
         8 - 11 . (canceled) 
     
     
         12 . The method of  claim 1  wherein measuring comprises:
 (a) providing a subject sample of blood or a blood derivative; 
 (b) fractionating proteins in the sample on an anion exchange resin and collecting fractions that contain ApoA1, transthyretin ΔN10 and IAIH4 fragment; and 
 (c) capturing ApoA1, transthyretin ΔN10 and IAIH4 fragment from the fractions on a surface of a substrate comprising capture reagents that bind the protein biomarkers. 
 
     
     
         13 - 24 . (canceled) 
     
     
         25 . A method comprising:
 (a) measuring a plurality of biomarkers in a sample from the subject, wherein the biomarkers are selected from the group consisting of ApoA1, transthyretin ΔN10 and IAIH4 fragment.   
     
     
         26 - 30 . (canceled) 
     
     
         31 . A method comprising:
 (a) measuring at least one biomarker in a sample from a subject, wherein the biomarker is selected from the group consisting of transthyretin ΔN10 and IAIH4 fragment and combinations thereof.   
     
     
         32 . The method of  claim 31  further comprising measuring ApoA1. 
     
     
         33 . The method of  claim 31  further comprising measuring at least one known biomarker. 
     
     
         34 - 36 . (canceled) 
     
     
         37 . A kit comprising:
 (a) a capture reagent that binds a biomarker selected from ApoA1, transthyretin ΔN10 and IAIH4 fragment and combinations thereof; and   (b) a container comprising at least one of the biomarkers.   
     
     
         38 - 41 . (canceled) 
     
     
         42 . A kit comprising:
 (a) a first capture reagent that binds at least one biomarker selected from ApoA1, transthyretin ΔN10 and IAIH4 fragment and   (b) a second capture reagent that binds at least one of the biomarkers that is not bound by the first capture reagent.   
     
     
         43 - 46 . (canceled) 
     
     
         47 . A kit comprising:
 (a) a first capture reagent that binds at least one biomarker selected from ApoA1, transthyretin ΔN10 and IAIH4 fragment and   (b) instructions for using the capture reagent to detect the biomarker.   
     
     
         48 - 53 . (canceled) 
     
     
         54 . A purified peptide of SEQ ID NO:1 (IAIH4 fragment). 
     
     
         55 . The peptide of  claim 54  further comprising a detectable label. 
     
     
         56 - 60 . (canceled) 
     
     
         61 . A screening test comprising:
 (a) contacting a kallikrein with a kallikrein substrate and with a test agent and   (b) determining whether the test agent modulates the activity of the kallikrein.   
     
     
         62 . The test of  claim 61  wherein the substrate is inter-alpha-trypsin inhibitor heavy chain H4 precursor. 
     
     
         63 . The test of  claim 61  wherein the kallikrein cleaves the substrate into IAIH4 fragment. 
     
     
         64 . The test of  claim 61 , wherein the determining step further comprises measuring biomarker IAIH4 fragment. 
     
     
         65 - 66 . (canceled) 
     
     
         67 . A method of qualifying ovarian cancer status in a subject comprising:
 (a) measuring at least one biomarker in a sample from the subject, wherein the biomarker is selected from the group consisting of Markers I through XLVIII and combinations thereof, and   (b) correlating the measurement with ovarian cancer status.   
     
     
         68 . The method of  claim 67  further comprising:
 (c) managing subject treatment based on the status. 
 
     
     
         69 - 70 . (canceled) 
     
     
         71 . The method of  claim 67  wherein the ovarian cancer status is selected from the group consisting of the subject's risk of cancer, the presence or absence of disease, the stage of disease and the effectiveness of treatment of disease. 
     
     
         72 . The method of  claim 67  further comprising measuring at least one known biomarker in a sample from the subject and correlating measurement of at least one known biomarker and the measurement of least marker of the group consisting of Markers I through XLVIII with ovarian cancer status. 
     
     
         73 - 77 . (canceled)