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)
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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 (5)
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 →
PATENT SECURITY AGREEMENT
Recorded Feb 3, 2026
From: EXACT SCIENCES CORPORATION
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 074613/0193 →
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 →
Continuity (4)
Provisional Application
62928888
· Oct 31, 2019
Provisional Application
63065081
· Aug 13, 2020
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