MULTIGENE DIAGNOSTIC ASSAY FOR MALIGNANT THYROID NEOPLASM

• US 20080280302A1
• Filed: 05/08/2008
• Published: 11/13/2008
• Est. Priority Date: 05/09/2007
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Kebebew, Electron
• Granted Patent: US 7,901,888 B2
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/112 Disease subtyping, staging or classification
• CPC Class Codes: G01N 2800/50 Determining the risk of developing a disease
• CPC Class Codes: G01N 2800/56 Staging of a disease; Further complications associated with the disease
• CPC Class Codes: G01N 33/57407 Specifically defined cancers

Abstract

The present invention provides methods for diagnosing, providing a prognosis, and staging thyroid cancer, using panels of molecular markers that are differentially expressed in thyroid cancer. Also provided are methods to identify compounds that are useful for the treatment or prevention of thyroid cancer.

Claims

1. A method of diagnosing thyroid cancer in a subject, the method comprising the steps of:

(a) contacting a biological sample from the subject with reagents that specifically bind to a panel of biomarkers comprising ECM1, TMPRSS4, ANGPT2, and T1MP1, and

(b) determining whether or not the marker is differentially expressed in the sample;

thereby providing a diagnosis for thyroid cancer.

2. The method of claim 1, wherein the reagent is an antibody.

3. The method of claim 2, wherein the antibody is monoclonal.

4. The method of claim 1, wherein the reagent is a nucleic acid.

5. The method of claim 1, wherein the reagent is an oligonucleotide.

6. The method of claim 1, wherein the reagent is an RT PCR primer set.

7. The method of claim 1, wherein the sample is a fine needle aspiration biopsy.

8. The method of claim 1, wherein the biomarker panel further comprises EFNB2 and EGFR.

9. A method of determining the stage of thyroid cancer in a subject, the method comprising the steps of:

(a) contacting a biological sample from the subject with reagents that specifically bind to a panel of biomarkers comprising ECM1, EFNB2 and EGFR, and

(b) determining whether or not the marker is differentially expressed in the sample;

thereby staging the thyroid cancer.

10. The method of claim 9, wherein the reagent is an antibody.

11. The method of claim 10, wherein the antibody is monoclonal.

12. The method of claim 9, wherein the reagent is a nucleic acid.

13. The method of claim 9, wherein the reagent is an oligonucleotide.

14. The method of claim 9, wherein the reagent is an RT PCR primer set.

15. The method of claim 9, wherein the sample is a fine needle aspiration biopsy.

16. The method of claim 9, wherein the biomarker panel further comprises TMPRSS4, ANGPT2, and T1MP1.

17. A method of distinguishing low risk and high risk differentiated thyroid cancers in a subject, the method comprising the steps of:

(a) contacting a biological sample from the subject with reagents that specifically bind to a panel of biomarkers comprising ECM1, EFNB2 and EGFR, and

(b) determining whether or not the marker is differentially expressed in the sample;

thereby determining the risk associated with the thyroid cancer.

18. The method of claim 17, wherein the reagent is an antibody.

19. The method of claim 18, wherein the antibody is monoclonal.

20. The method of claim 17, wherein the reagent is a nucleic acid.

21. The method of claim 17, wherein the reagent is an oligonucleotide.

22. The method of claim 17, wherein the reagent is an RT PCR primer set.

23. The method of claim 17, wherein the sample is a fine needle aspiration biopsy.

24. The method of claim 17, wherein the biomarker panel further comprises TMPRSS4, ANGPT2, and T1MP1.

25. A kit comprising reagents that specifically bind to a panel of biomarkers comprising ECM1, TMPRSS4, ANGPT2, and T1MP1.

26. A kit comprising reagents that specifically bind to a panel of biomarkers comprising ECM1, EFNB2 and EGFR.

27. A kit comprising reagents that specifically bind to a panel of biomarkers comprising ECM1, TMPRSS4, ANGPT2, T1MP1, EFNB2 and EGFR.