# US 10,865,448 B2 · Compositions and methods relating to DENND1A variant 2 and polycystic ovary syndrome

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,865,448 B2
- Document ID: US10865448B2
- Status: Granted
- Kind: B2
- Application number: 15/921,712
- Filed: 2018-03-15
- Published: 2018-08-02
- Granted: 2020-12-15
- Earliest claimed: 2012-05-21
- Assignees: The Penn State Research Foundation; Virginia Commonwealth University
- Applicants: The Penn State Research Foundation; Virginia Commonwealth University
- Inventors: Janette M McAllister; Jerome F Strauss
- Web page: https://patentgrep.com/patent/US10865448B2

## CPC

- C12Q 1/6883: for diseases caused by alterations of genetic material
- G01N 33/53: Immunoassay; Biospecific binding assay; Materials therefor
- G01N 33/561: Immunoelectrophoresis
- C12Q 2600/112: Disease subtyping, staging or classification
- C12Q 2600/156: Polymorphic or mutational markers
- 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
- 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)

## Abstract

Provided are compositions and methods for use in polycystic ovary syndrome diagnosis (PCOS). The method involves a sample from a subject for a DENND1A Variant 2 mRNA or DENND1 A Variant 2 protein to make or aid in a diagnosis of PCOS. Also provided are methods for selecting an individual as a candidate for therapy for polycystic ovary syndrome by testing a biological sample from an individual for DENND1 A Variant 2 mRNA or DENND1 A Variant 2 protein and designating the individual as a candidate for the PCOS based on determining DENND1 A Variant 2 mRNA or DENND1 A Variant 2 protein in the sample. Also provided are products for use in aiding diagnosis of PCOS which contain reagents for detecting DENND1 A Variant 2 mRNA or DENND1 A Variant 2 protein, and packaging containing printed material describing use and indications for the product.

## Claims

### Claim 1

A method for polycystic ovary syndrome diagnosis, the method comprising the steps of:
measuring an amount of DENND1A Variant 2 protein in a biological sample from a subject, wherein measuring the amount of DENND1A Variant 2 protein is performed using a composition comprising antibodies, wherein the antibodies are bound to the DENND1A Variant 2 protein, wherein the binding of the antibodies to the DENND1A Variant 2 protein is detected, and wherein the antibodies specifically recognize at least one epitope in a segment of the DENND1A Variant 2 protein consisting of the 33 amino acids at its C-terminus, wherein the DENND1A Variant 2 protein is contacted with the antibodies and wherein antibodies bound to the segment are detected;
comparing the amount of DENND1A Variant 2 protein to a reference value; and
diagnosing said subject with polycystic ovary syndrome when said amount of DENND1A Variant 2 protein is increased as compared to the reference value.

### Claim 2

A method for selecting an individual as a candidate for therapy for polycystic ovary syndrome, the method comprising the steps of:
measuring an amount of DENND1A Variant 2 protein in a biological sample from said individual, wherein measuring the DENND1A Variant 2 protein is performed using a composition comprising antibodies, wherein the antibodies are hybridized bound to the DENND1A Variant 2 protein, wherein the binding of the antibodies to the DENND1A Variant 2 protein is detected, and wherein the antibodies specifically recognize at least one epitope in a segment of the DENND1A Variant 2 protein consisting of the 33 amino acids at its C-terminus, wherein the DENND1A Variant 2 protein is contacted with the antibodies and wherein antibodies bound to the segment are detected;
diagnosing said individual with polycystic ovary syndrome when said amount of DENND1A Variant 2 protein is increased as compared to the reference value; and
designating the individual diagnosed with polycystic ovary syndrome as a candidate for the polycystic ovary syndrome therapy.

### Claim 3 (depends on 1)

The method of claim 1, wherein the biological sample is selected from a sample comprising urine, blood, plasma, serum or saliva.

### Claim 4 (depends on 2)

The method of claim 2, wherein the biological sample is selected from a sample comprising urine, blood, plasma, serum or saliva.