Predictive markers for ovarian cancer

• US 8,664,358 B2
• Filed: 06/30/2008
• Issued: 03/04/2014
• Est. Priority Date: 06/29/2007
• Status: Active Grant

• Current Assignee: Aspira Women's Health, Inc.
• Original Assignee: Vermillion, Inc.
• Inventors: Mansfield, Brian C., Yip, Ping F., Amonkar, Suraj, Bertenshaw, Greg P.
• Primary Examiner(s): Shen, Bin
• Application Number:
  US12/165,240
• Publication Number:
  US 20090004687A1
• Time in Patent Office: 2,073 Days
• Field of Search: 530/350
• US Class Current: 530/350
• CPC Class Codes: G01N 2800/50 Determining the risk of developing a disease
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 2800/60 Complex ways of combining multiple protein biomarkers for diagnosis
• CPC Class Codes: G01N 33/57449 of ovaries
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

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

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.