IP Library Granted Patent US 12,442,043
Granted Patent B2
US 12,442,043 · App. 18/327,614 · Granted Oct 14, 2025

Detecting ovarian cancer

Inventors: William R. Taylor (Lake City, MN); John B. Kisiel (Rochester, MN); Douglas W. Mahoney (Elgin, MN); David A. Ahlquist (Rochester, MN); Hatim T. Allawi (Middleton, WI); Michael W. Kaiser (Stoughton, WI)
Assignees: Mayo Foundation for Medical Education and Research; Exact Sciences Corporation
C12Q1/6886C12N15/117C12Q1/6869G01N33/50C12Q2521/301C12Q2523/125
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,442,043
App. No.
18/327,614
Granted
Oct 14, 2025
Kind
B2
Abstract

Provided herein is technology for ovarian cancer screening and particularly, but not exclusively, to methods, compositions, and related uses for detecting the presence of ovarian cancer and sub-types of ovarian cancer (e.g., clear cell ovarian cancer, endometrioid ovarian cancer, mucinous ovarian cancer, serous ovarian cancer).

Claims (20)

1. A method comprising:

treating genomic DNA from a sample from a subject having or suspected of having ovarian cancer with a reagent that modifies DNA in a methylation-specific manner;

amplifying the treated genomic DNA using a set of primers specific for each of CDO1 and SIM2; and

determining a methylation level of at least one differentially methylated region (DMR) in each of CDO1 and SIM2 using polymerase chain reaction (PCR), nucleic acid sequencing, mass spectrometry, restriction enzyme analysis, mass-based separation, and/or target capture.

2. The method of claim 1 , wherein the sample comprises one or more of a plasma sample, a whole blood sample, a leukocyte sample, a serum sample, and/or a tissue sample.

3. The method of claim 1 , wherein:

the at least one DMR in CDO1 is selected from CDO1_A and CDO1_B; and

the at least one DMR in SIM2 is selected from SIM2_A and SIM2_B.

4. The method of claim 1 , further comprising measuring a level of cancer antigen 125 (CA-125) in the sample.

5. The method of claim 1 , wherein the reagent that modifies DNA in a methylation-specific manner is a bisulfite reagent.

6. The method of claim 1 , wherein determining the methylation level of the at least one DMR in each of CDO1 and SIM2 comprises using one or more methods selected from the group consisting of methylation-specific PCR, quantitative methylation-specific PCR, methylation-specific DNA restriction enzyme analysis, quantitative bisulfite pyrosequencing, flap endonuclease assay analysis, PCR-flap assay analysis, and/or bisulfite genomic sequencing PCR.

7. The method of claim 1 , wherein amplifying the treated genomic DNA comprises:

using primers specific for a CpG site in CDO1, wherein the primers specifically bind at least a portion of a genetic region comprising chromosome 5 coordinates 115152022-115152432 or chromosome 5 coordinates 115152466-115152505; and

using primers specific for a CpG site in SIM2, wherein the primers specifically bind at least a portion of a genetic region comprising chromosome 21 coordinates 38076892-38077026 or chromosome 21 coordinates 38076882-38077036.

8. The method of claim 1 , wherein the at least one DMR is present in a coding region or a regulatory region of CDO1 and SIM2.

9. The method of claim 1 , wherein the ovarian cancer is at least one of clear cell ovarian cancer, endometrioid ovarian cancer, mucinous ovarian cancer, and/or serous ovarian cancer.

10. The method of claim 1 , wherein the method further comprises amplifying the treated genomic DNA using a set of primers for one or more genes selected from FAIM2, CAPN2, and/or IFFO1.

11. The method of claim 10 , wherein the one or more genes is FAIM2.

12. The method of claim 10 , wherein the one or more genes is CAPN2.

13. The method of claim 10 , wherein the one or more genes is IFFO1.

Assignments (4)
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENT RIGHTS (JANUARY 2026) Recorded Mar 27, 2026
From: JPMORGAN CHASE BANK, N.A.
To: EXACT SCIENCES CORPORATION
Reel/Frame 075288/0517 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 16, 2023
From: TAYLOR, WILLIAM R.; KISIEL, JOHN B.; MAHONEY, DOUGLAS W.; AHLQUIST, DAVID A.
To: MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
Reel/Frame 063970/0853 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 16, 2023
From: ALLAWI, HATIM T.; KAISER, MICHAEL W.
To: EXACT SCIENCES DEVELOPMENT COMPANY, LLC,
Reel/Frame 063970/0904 →
MERGER Recorded Jun 16, 2023
From: EXACT SCIENCES DEVELOPMENT COMPANY, LLC,
To: EXACT SCIENCES CORPORATION
Reel/Frame 063971/0129 →