METHODS AND COMPOSITIONS FOR THE DETECTION OF OVARIAN DISEASE

• US 20090081685A1
• Filed: 11/11/2008
• Published: 03/26/2009
• Est. Priority Date: 07/09/2004
• Status: Abandoned Application

• Current Assignee: Tripath Imaging Incorporated (Becton, Dickinson & Co)
• Original Assignee: Tripath Imaging Incorporated (Becton, Dickinson & Co)
• Inventors: Blaesius, Rainer H., Venetta, Thomas M., Beyer, Wayne F., Groelke, John W.
• Application Number:
  US12/268,850
• Publication Number:
  US 20090081685A1
• 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: C12Q 2600/158 Expression markers
• CPC Class Codes: G01N 2333/4725 Mucins, e.g. human intestinal mucin
• CPC Class Codes: G01N 33/57449 of ovaries
• CPC Class Codes: G01N 33/57488 involving compounds identifable in body fluids

Abstract

Methods and compositions for identifying ovarian cancer in a patient sample are provided. The methods of the invention comprise detecting overexpression of at least one biomarker in a body sample, wherein the biomarker is selectively overexpressed in ovarian cancer. In preferred embodiments, the body sample is a serum sample. The biomarkers of the invention include any genes or proteins that are selectively overexpressed in ovarian cancer, including, for example, acute phase reactants, lipoproteins, proteins involved in the regulation of the complement system, regulators of apoptosis, proteins that bind hemoglobin, heme, or iron, cytostructural proteins, enzymes that detoxify metabolic byproducts, growth factors, and hormone transporters. In some aspects of the invention, overexpression of a biomarker of interest is detected at the protein level using biomarker-specific antibodies or at the nucleic acid level using nucleic acid hybridization techniques. Kits for practicing the methods of the invention are further provided.

Claims

1. A method for diagnosing ovarian cancer in a patient, the method comprising detecting expression of at least one biomarker in a body sample, wherein the at least one biomarker is selected from the group consisting of plasma glutathione peroxidase, serum amyloid A4, and vitronectin, and wherein the detection of overexpression of the at least one biomarker specifically identifies samples that are indicative of ovarian cancer.

2. The method of claim 1, wherein the method comprises detecting expression of at least two biomarkers in a body sample, wherein the detection of overexpression of the at least two biomarkers specifically identifies samples that are indicative of ovarian cancer.

3. The method of claim 1, wherein the method comprises detecting expression of at least three biomarkers in a body sample, wherein the detection of overexpression of the at least three biomarkers specifically identifies samples that are indicative of ovarian cancer.

4. The method of claim 1, wherein detecting expression of the at least one biomarker is performed at the nucleic acid level.

5. The method of claim 4, wherein detecting expression of the at least one biomarker comprises nucleic acid hybridization.

6. The method of claim 1, wherein detecting expression of the at least one biomarker is performed at the protein level.

7. The method of claim 6, wherein detecting expression of the at least one biomarker comprises using at least one antibody to detect biomarker protein expression.

8. The method of claim 1, wherein the detection of overexpression of at least one biomarker distinguishes samples that are indicative of ovarian cancer from samples that are indicative of benign proliferation.

9. The method of claim 1, wherein the method permits the detection of early-stage ovarian cancer.

10. The method of claim 1, wherein the sample is a serum sample.

11. A method for diagnosing ovarian cancer in a patient, the method comprising:

a) obtaining a body sample from the patient;

b) contacting the sample with at least one antibody, wherein the at least one antibody specifically binds to a biomarker protein that is selectively overexpressed in ovarian cancer, and wherein the biomarker protein is selected from the group consisting of plasma glutathione peroxidase, serum amyloid A4 protein, and vitronectin; and

,

c) detecting binding of the at least one antibody to the biomarker protein to detect expression of the biomarker protein, wherein the detection of overexpression of the biomarker protein specifically identifies samples that are indicative of ovarian cancer, and thereby diagnosing ovarian cancer in the patient.

12. The method of claim 11, wherein said antibody is a monoclonal antibody.

13. A method for diagnosing ovarian cancer in a patient, the method comprising:

a) obtaining a body sample from the patient;

b) contacting the sample with at least two antibodies, wherein the at least two antibodies comprise a first capture antibody that is immobilized on a solid support and a second labeled detection antibody, wherein the capture antibody and the detection antibody each specifically bind to a distinct antigenic site on a biomarker protein that is selectively overexpressed in ovarian cancer, and wherein the biomarker protein is selected from the group consisting of plasma glutathione peroxidase, serum amyloid A4 protein, and vitronectin; and

,

c) detecting binding of the labeled antibody to the biomarker protein to detect expression of the biomarker protein, wherein the detection of overexpression of the biomarker protein specifically identifies samples that are indicative of ovarian cancer, and thereby diagnosing ovarian cancer in the patient.

14. A kit comprising at least one antibody, wherein said antibody specifically binds to a biomarker protein that is selectively overexpressed in ovarian cancer, and wherein said biomarker is selected from the group consisting of plasma glutathione peroxidase, serum amyloid A4 protein, and vitronectin.

15. The kit of claim 14, wherein the kit comprises at least two antibodies, wherein each of said antibodies specifically binds to a biomarker protein that is selectively overexpressed in ovarian cancer.

16. The kit of claim 14, wherein the kit comprises at least three antibodies, wherein each of said antibodies specifically binds to a biomarker protein that is selectively overexpressed in ovarian cancer.

17. The kit of claim 15, wherein the kit comprises a first capture antibody that is immobilized on a solid support and a second labeled detection antibody, wherein the capture antibody and the detection antibody each specifically bind to a distinct antigenic site on a biomarker protein that is selectively overexpressed in ovarian cancer.