IP Library Granted Patent US 8,664,358
Granted Patent B2
US 8,664,358 · App. 12/165,240 · Granted Mar 4, 2014

Predictive markers for ovarian cancer

Inventors: Brian C. Mansfield (Catonsville, MD); Ping F. Yip (Winchester, MA); Suraj Amonkar (McLean, VA); Greg P. Bertenshaw (Gaithersburg, MD)
Assignee: Vermillion, Inc.
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Quick Facts
Patent No.
US 8,664,358
App. No.
12/165,240
Granted
Mar 4, 2014
Kind
B2
Abstract

Methods are provided for predicting the presence, subtype and stage of ovarian cancer, as well as for assessing the therapeutic efficacy of a cancer treatment and determining whether a subject potentially is developing cancer. Associated test kits, computer and analytical systems as well as software and diagnostic models are also provided.

Claims (23)

1. A set of reagents to measure the levels of biomarkers in a specimen, wherein the biomarkers are selected from the group consisting of the following panels of biomarkers and their measurable fragments: (a) CA-125, CRP, EGF-R, CA-19-9, Apo-AI, Apo-CIII, IL-6, IL-18, MIP-1a, Tenascin C and Myoglobin; (b) CA-125, CRP, EGF-R, CA-19-9, Apo-AI, Apo-CIII, IL-6, MIP-1a, Tenascin C and Myoglobin; (c) CA19-9, CA125, CRP, and EGFR; (d) CA19-9, CA125, CRP, EGFR, ApoCIII, IL-18, and Myoglobin; (e) CA19-9, CA125, CRP, EGFR, IL-6, IL-18, and MIP1a; (f) CA19-9, CA125, CRP, EGFR, IL-18, MIP1a, and Myoglobin; (g) CA19-9, CA125, CRP, EGFR, ApoCIII, IL-18, and Myoglobin; (h) CA19-9, CA125, CRP, EGFR, IL-6, IL-18, and Myoglobin; (i) CA19-9, CA125, CRP, EGFR, ApoA1, MIP1a, and Myoglobin; (j) CA19-9, CA125, CRP, EGFR, ApoCIII, MIP1a, and Myoglobin; and (k) CA19-9, CA125, CRP, EGFR, ApoCIII, IL-6, and MIP1a, the set of reagents having a sensitivity and specificity of about 85% in a population that is symptomatic for ovarian cancer.

2. The set of reagents of claim 1 , wherein one or more of the biomarkers may be replaced by a molecule, or a measurable fragment of the molecule, found upstream or downstream of the biomarker in a biological pathway.

3. The set of reagents of claim 1 , wherein the reagents are binding molecules.

4. The set of reagents of claim 3 , wherein the binding molecules are antibodies.

5. A test kit comprising the set of reagents of claim 1 .

6. A multianalyte panel assay kit comprising the set of reagents of claim 1 .

7. A set of reagents to measure the levels of three or more biomarkers in a specimen, wherein the biomarkers comprise CA125, CRP and CA-19-9 and their measurable fragments, said set of reagents having a sensitivity and specificity of about 85% in a population that is symptomatic for ovarian cancer.

8. The set of reagents of claim 7 , wherein the biomarkers further comprise EGF-R and its measurable fragments.

9. The set of reagents of claim 7 , wherein one or more of the three or more biomarkers may be replaced by a molecule, or a measurable fragment of the molecule, found upstream or downstream of the biomarker in a biological pathway.

10. The set of reagents of claim 7 , wherein the reagents are binding molecules.

11. The set of reagents of claim 10 , wherein the binding molecules are antibodies.

12. A test kit comprising the set of reagents of claim 7 .

13. A multianalyte panel assay kit comprising the set of reagents of claim 7 .

14. The multianalyte panel assay kit of claim 13 , further comprising written instructions for performing an evaluation of biomarkers to predict the likelihood of ovarian cancer in a subject.

15. The test kit of claim 12 , further comprising written instructions for performing an evaluation of biomarkers to predict the likelihood of ovarian cancer in a subject.

16. A set of reagents to measure the levels of three or more biomarkers in a specimen, wherein the biomarkers comprise CA125, CRP and EGF-R and their measurable fragments, said set of reagents having a sensitivity and specificity of about 85% in a population that is symptomatic for ovarian cancer.

17. The set of reagents of claim 16 , wherein one or more of the biomarkers may be replaced by a molecule, or a measurable fragment of the molecule, found upstream or downstream of the biomarker in a biological pathway.

18. The set of reagents of claim 16 , wherein the reagents are binding molecules.

19. The set of reagents of claim 17 , wherein the binding molecules are antibodies.

20. A test kit comprising the set of reagents of claim 16 .

21. The test kit of claim 20 , further comprising written instructions for performing an evaluation of biomarkers to predict the likelihood of ovarian cancer in a subject.

22. A multianalyte panel assay kit comprising the set of reagents of claim 16 .

23. The multianalyte panel assay kit of claim 22 , further comprising written instructions for performing an evaluation of biomarkers to predict the likelihood of ovarian cancer in a subject.

Assignments (4)
CHANGE OF NAME Recorded Aug 14, 2020
From: VERMILLION, INC.
To: ASPIRA WOMEN'S HEALTH INC.
Reel/Frame 053499/0896 →
SECURITY INTEREST Recorded Mar 24, 2016
From: VERMILLION, INC.
To: STATE OF CONNECTICUT DEPARTMENT OF ECONOMIC AND COMMUNITY DEVELOPMENT
Reel/Frame 038087/0448 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2012
From: CORRELOGIC SYSTEMS, INC.
To: VERMILLION, INC.
Reel/Frame 027799/0239 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 3, 2008
From: MANSFIELD, BRIAN C.; YIP, PING F.; AMONKAR, SURAJ; BERTENSHAW, GREG P.
To: CORRELOGIC SYSTEMS, INC.
Reel/Frame 021195/0099 →
Continuity (3)
Provisional Application 60947253 · Jun 29, 2007
Provisional Application 61037946 · Mar 19, 2008
Related Publication 20090004687A1 · Jan 1, 2009