# US 9,040,464 B2 · Markers of the male urogenital tract > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,040,464 B2 - Document ID: US9040464B2 - Status: Granted - Kind: B2 - Application number: 13/814,959 - Filed: 2011-08-16 - Published: 2013-08-15 - Granted: 2015-05-26 - Earliest claimed: 2010-08-16 - Assignees: Mount Sinai Hosptial - Applicants: Keith Jarvi; Eleftherios P. Diamandis; Andrei Drabovich - Inventors: Keith Jarvi; Eleftherios P. Diamandis; Andrei Drabovich - Web page: https://patentgrep.com/patent/US9040464B2 ## CPC - G01N 33/6893: {related to diseases not provided for elsewhere} - C12Q 1/6883: for diseases caused by alterations of genetic material - G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)} - G01N 33/689: {related to pregnancy or the gonads} - C12Q 2600/136: Screening for pharmacological compounds - C12Q 2600/158: Expression markers - G01N 2333/705: Assays involving receptors, cell surface antigens or cell surface determinants - G01N 2333/78: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG] - G01N 2800/34: Genitourinary disorders - G01N 2800/342: Prostate diseases, e.g. BPH, prostatitis - G01N 2800/367: Infertility, e.g. sperm disorder, ovulatory dysfunction - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES ## 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. ## Claims ### Claim 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 ECM1 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). ### Claim 2 (depends on 1) A method of claim 1 wherein the contacting step further comprises an antibody capable of detecting urogenital marker TEX101 and an antibody capable of detecting urogenital marker LDHC and the method differentiates NOA from OA. ### Claim 3 (depends on 1) 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. ### Claim 4 (depends on 1) 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. ### Claim 5 (depends on 1) 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. ### Claim 6 (depends on 1) A method of claim 1, wherein the contacting step further comprises an antibody capable of detecting the urogenital marker TEX101. ### Claim 7 (depends on 1) A method of claim 1, wherein the contacting step further comprises an antibody capable of detecting the urogenital marker LDHC. ### Claim 8 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 ECM1 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 ECM1 in the sample relative to a level of expression of ECM1 in a control subject who does not suffer from NOA or a post-vasectomy subject. ### Claim 9 (depends on 8) A method of claim 8, further comprising: analyzing the level of expression of TEX101 in the sample and correlating a diagnosis of NOA or OA with a change in the level of expression each of TEX101 and ECM1 in the sample relative to a level of expression each of TEX101 and ECM1 in the control subject. ### Claim 10 A method for diagnosis of a urogenital condition in a male subject, wherein the urogenital condition is characterized by the presence of ECM1 biomarker comprising: (a) obtaining a biological sample from the subject; (b) applying an antibody specific for ECM1 to the sample, wherein the presence of ECM1 biomarker creates an antibody-ECM1 biomarker complex; (c) applying a detection agent that detects the antibody-ECM1 biomarker complex; and (d) diagnosing the urogenital condition by detecting a change in the amount of antibody-ECM1 biomarker complex as compared to the amount of antibody-ECM1 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). ### Claim 11 (depends on 10) A method of claim 10, further comprising: applying an antibody specific for TEX101 to the sample, wherein the presence of TEX101 biomarker creates an antibody-TEX101 biomarker complex; applying a second detection agent that detects the antibody-TEX101 biomarker complex; and 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 the control sample and a change in the amount of antibody-ECM1 biomarker complex as compared to the amount of antibody-ECM1 biomarker complex in the control sample.