Diagnostic methods

• US 8,053,198 B2
• Filed: 09/12/2008
• Issued: 11/08/2011
• Est. Priority Date: 09/14/2007
• Status: Active Grant

• Current Assignee: Meso Scale Technologies, LLC
• Original Assignee: Meso Scale Technologies, LLC
• Inventors: Stengelin, Martin, Mathew, Anu, Glezer, Eli
• Primary Examiner(s): AEDER, SEAN E
• Application Number:
  US12/209,701
• Publication Number:
  US 20090075299A1
• Time in Patent Office: 1,152 Days
• Field of Search: None
• US Class Current: 435/7.1
• CPC Class Codes: G01N 2333/475 Assays involving growth factors
• CPC Class Codes: G01N 2333/71 for growth factors; for growth regulators
• CPC Class Codes: G01N 2333/91215 with a definite EC number (2.7.1.-)
• CPC Class Codes: G01N 2333/96419 Metalloendopeptidases (3.4.24)
• CPC Class Codes: G01N 2800/60 Complex ways of combining multiple protein biomarkers for diagnosis
• CPC Class Codes: G01N 33/57442 of the uterus and endometrial
• CPC Class Codes: G01N 33/57449 of ovaries

Abstract

The present invention relates to methods of diagnosing cancerous conditions in a patient, as well as methods of monitoring the progression of a cancerous condition and/or methods of monitoring a treatment protocol of a therapeutic agent or a chemotherapeutic regimen. The invention also relates to assay methods used in connection with the diagnostic methods described herein.

Claims

1. A method for diagnosing ovarian cancer in a patient comprising:

(a) measuring a level of a first biomarker in a serum, plasma, or a combination of serum and plasma sample obtained from a patient, wherein said first biomarker is Flt-1;

(b) comparing said level of said first biomarker in said sample to a level of said first biomarker in a normal control sample, wherein a level of said first biomarker in said sample that is more than one standard deviation above said level of said first biomarker in said normal control is indicative of the presence of ovarian cancer in said patient; and

(c) diagnosing from said measuring step and said comparing step the presence or absence of ovarian cancer in said patient.

2. The method of claim 1 wherein said method further comprises measuring a level of at least one additional biomarker in said sample, comparing said level of said at least one additional biomarker in said sample to a level of said at least one additional biomarker in a normal control sample, wherein a level of said at least one additional biomarker in said sample that is more than one standard deviation above said level of said at least one additional biomarker in said normal control is indicative of the presence of ovarian cancer in said patient, and determining from said level of said first biomarker and said level of said at least one additional biomarker the presence or absence of ovarian cancer in said patient.

3. The method of claim 2 wherein said at least one additional biomarker is selected from the group consisting of CA125, IL-6, CRP, SM, IL-8, IL-1β

, IL-2, P-Cadherin, Eotaxin-3, TNFR1, OPN, Prolactin, MMP-10, PIGF, and combinations thereof.

4. The method of claim 1 wherein said patient is a premenopausal woman or a postmenopausal woman.

5. The method of claim 1, wherein said measuring step is conducted on a single sample.

6. The method of claim 1, wherein said measuring step is conducted in a single assay chamber.

7. The method of claim 6, wherein said assay chamber is a single well of an assay plate.

8. The method of claim 6, wherein said assay chamber is an assay chamber of a cartridge.

9. The method of claim 1, wherein said sample is selected from the group consisting of blood, serum and plasma.

10. The method of claim 1, wherein said level is measured using an immunoassay.

11. The method of claim 1 wherein the sample is serum.

12. The method of claim 1 wherein said ovarian cancer is non-mucinous ovarian cancer.

13. The method of claim 12 wherein said patient is premenopausal.

14. The method of claim 12 wherein said patient is postmenopausal.

15. The method of claim 1 wherein said ovarian cancer is mucinous ovarian cancer.

16. The method of claim 15 wherein said patient is premenopausal.

17. The method of claim 15 wherein said patient is postmenopausal.

18. The method of claim 1 wherein a level of said first biomarker in said sample that is more than 1.5 standard deviations above said level of said first biomarker in said normal control is indicative of the presence of ovarian cancer in said patient.

19. The method of claim 2 wherein a level of said at least one additional biomarker in said sample that is more than 1.5 standard deviations above said level of said at least one additional biomarker in said normal control is indicative of the presence of ovarian cancer in said patient.

20. The method of claim 1 wherein a level of said first biomarker in said sample that is more than 2.0 standard deviations above said level of said first biomarker in said normal control is indicative of the presence of ovarian cancer in said patient.

21. The method of claim 2 wherein a level of said at least one additional biomarker in said sample that is more than 2.0 standard deviations above said level of said at least one additional biomarker in said normal control is indicative of the presence of ovarian cancer in said patient.

22. The method of claim 1 wherein a level of said first biomarker in said sample that is more than 2.5 standard deviations above said level of said first biomarker in said normal control is indicative of the presence of ovarian cancer in said patient.

23. The method of claim 2 wherein a level of said at least one additional biomarker in said sample that is more than 2.5 standard deviations above said level of said at least one additional biomarker in said normal control is indicative of the presence of ovarian cancer in said patient.

24. The method of claim 1 wherein a level of said first biomarker in said sample that is more than 3.0 standard deviations above said level of said first biomarker in said normal control is indicative of the presence of ovarian cancer in said patient.

25. The method of claim 2 wherein a level of said at least one additional biomarker in said sample that is more than 3.0 standard deviations above said level of said at least one additional biomarker in said normal control is indicative of the presence of ovarian cancer in said patient.

26. The method of claim 2 further comprising determining from said level of said at least one additional biomarker the disease progression of ovarian cancer.