Markers of the male urogenital tract

Abstract

Methods for detecting urogenital conditions or urogenital status in a subject are described comprising measuring urogenital markers or polynucleotides, encoding the markers in a sample from the subject. The invention also provides localization or imaging methods for urogenital conditions, and kits for carrying out the methods of the invention. The invention also contemplates therapeutic applications for urogenital conditions employing urogenital markers, polynucleotides encoding the markers, and/or binding agents for the markers.

What is claimed is: 
     
         1 . A method for diagnosis of a urogenital condition in a subject comprising:
 (a) contacting a sample of seminal plasma from the subject with an antibody capable of detecting a urogenital marker TEX101 in the sample using an enzyme linked immunosorbent assay (ELISA); and   (b) diagnosing the urogenital condition by detecting a change in the amount or status of the urogenital marker as compared to the amount or status of the same urogenital marker obtained from a control subject who does not suffer from the urogenital condition or a post-vasectomy subject,   wherein the urogenital condition is non-obstructive azoospermia (NOA) or obstructive azoospermia (OA).   
     
     
         2 . A method for diagnosing non-obstructive azoospermia (NOA) or obstructive azoospermia (OA) in a male subject, the method comprising:
 analyzing, in vitro, the level of expression of TEX101 in a sample from a human subject in an enzyme-linked immunosorbent assay;   and correlating a diagnosis of NOA or OA with a change in the level of expression of TEX101 in the sample relative to a level of expression of TEX101 in a control subject who does not suffer from NOA or a post-vasectomy subject.   
     
     
         3 . A method for diagnosis of a urogenital condition in a male subject, wherein the urogenital condition is characterized by the presence of TEX101 biomarker comprising:
 (a) obtaining a biological sample from the subject;   (b) applying an antibody specific for TEX101 to the sample, wherein the presence of TEX101 biomarker creates an antibody-TEX101 biomarker complex;   (c) applying a detection agent that detects the antibody-TEX10 lbiomarker complex; and   (d) diagnosing the urogenital condition by detecting a change in the amount of antibody-TEX101 biomarker complex as compared to the amount of antibody-TEX101 biomarker complex in a sample obtained from a control subject who does not suffer from the urogenital condition or a post-vasectomy subject,   wherein the urogenital condition is non-obstructive azoospermia (NOA) or obstructive azoospermia (OA).   
     
     
         4 . A method of  claim 1 , wherein the contacting step further comprises at least one additional antibody, each antibody capable of detecting one of the urogenital markers PTGDS, CEL, MUC15, SPAG11B, ALDH1A1, GPR64, CA4 and ADAM7. 
     
     
         5 . A method of  claim 1 , wherein the contacting step further comprises at least one additional antibody, each antibody capable of detecting one of the urogenital markers CRISP1, FAM12B, SPINT3, CAMP, PTGDS, CES7, ADAM7, MGAM, SPAG11B, MUC15, CEL, NPC2, CA4 and GPR64. 
     
     
         6 . A method of  claim 1 , wherein the contacting step further comprises at least one additional antibody, each antibody capable of detecting one of the urogenital markers ADAM7, ALDH1A1, CA4, CAMP, CD177, CEL, CES7, CRISP1, FAM12B, GPR64, MGAM, MUC15, NPC2, PTGDS, SPAG11B and SPINT3. 
     
     
         7 . A diagnostic composition or kit comprising:
 (a) an agent that binds to a urogenital marker or hybridizes to a polynucleotide encoding such marker, wherein the urogenital markers are the markers of Table 1, 4, 6, 7, 8, 10, 11, 12 or 13; or   (b) a set of markers comprising a plurality of polypeptides comprising or consisting of at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 or more of the markers of Table 1, 2, 3, 4, 5, 6, 7, 8, 9 10, 11, 12 or 13; or   (c) an agent that binds to a urogenital marker or hybridizes to a polynucleotide encoding such marker, wherein the urogenital markers comprise at least TEX101.   
     
     
         8 . A kit for carrying out a method of  claim 1 . 
     
     
         9 . A method for identifying potentially infertile males or evaluating male fertility following an event which may influence the subject's fertility comprising determining the status of urogenital markers or polynucleotides encoding the markers in a sample obtained from the subject wherein the markers are the markers of a diagnostic composition or kit of  claim 7 . 
     
     
         10 . A method for diagnosing, monitoring or screening a subject for a urogenital condition comprising
 (a) obtaining a sample from a subject;   (b) detecting in proteins extracted from the sample the amount of one or more urogenital markers; and   (c) comparing the amount of urogenital markers detected to a predetermined standard,   wherein detection of a level of urogenital markers different than that of a standard is indicative of the urogenital condition, and wherein the urogenital markers are the markers of a diagnostic composition or kit of  claim 8 .   
     
     
         11 . A method of  claim 10 , wherein the urogenital condition is prostatitis and the urogenital markers are one or more markers of Table 8 or 9.