IP Library Granted Patent US 8,883,440
Granted Patent B2
US 8,883,440 · App. 12/670,854 · Granted Nov 11, 2014

Method to predict or diagnose a gastrointestinal disorder or disease

Inventor: Nancy M. Lee (San Francisco, CA)
C12Q1/6886C12Q1/6841C12Q2600/112C12Q2600/158
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Quick Facts
Patent No.
US 8,883,440
App. No.
12/670,854
Granted
Nov 11, 2014
Kind
B2
Abstract

The disclosure provides methods and compositions useful for identifying a subject's predisposition to a gastrointestinal disease or disorder.

Claims (31)

1. A method for determining if a human subject has an increased risk of having a gastrointestinal disease or disorder comprising:

measuring a family history or self-history of cancer with no polyps (“FHSH”) biomarker panel, a polyp biomarker panel, a rectal bleeding biomarker panel, a cancer biomarker panel or any combination thereof by using cDNA generated from RNA isolated from a sample obtained from the subject by using a swab of mucosal cells; and

indicating that the subject has an increased risk of having a gastrointestinal disease or disorder by measuring a change in the biomarker panel relative to a control.

2. The method of claim 1 , wherein the gastrointestinal disease or disorder is a gastrointestinal cancerous lesion.

3. The method of claim 2 , wherein the FHSH biomarker panel is obtained by biopsy.

4. The method of claim 3 , wherein the FHSH biomarker panel based upon a biopsy comprises one or more of the biomarkers GROα, PPARδ, SAA1, COX1 and CXCR2.

5. The method of claim 1 , wherein the FHSH biomarker panel comprises two or more of the biomarkers Groα, CD44, and COX1.

6. The method of claim 5 , wherein the FHSH biomarker panel comprises at least Groα, CD44, and COX1.

7. The method of claim 1 , wherein the subject has a family history or self-history if the FHSH biomarker panel measurements show a change in expression of a biomarker of at least 15% compared to a control subject population.

8. The method of claim 1 , wherein a subject that is identified as having a predisposition or risk of developing a polyp or cancerous lesion is monitored for a polyp biomarker panel.

9. The method of claim 8 , wherein the subject is further monitored for a cancer biomarker panel.

10. The method of claim 9 , wherein the cancer biomarker panel is obtained by swab in the absence of an RNA protection cocktail.

11. The method of claim 10 , wherein the cancer biomarker panel based upon a swab in the absence of an RNA protection cocktail comprises one or more of the biomarkers PPARα, CXCR2, cMyc and CD44.

12. The method of claim 9 , wherein the cancer biomarker panel based upon a swab is obtained in the presence of an RNA protection cocktail.

13. The method of claim 12 , wherein cancer biomarker panel based upon a swab in the presence of an RNA protection cocktail comprises one or more of the biomarkers COX2 and IL-8.

14. The method of claim 1 , wherein the polyp biomarker panel based upon a swab comprises one or more of the biomarkers CD44, PPARγ, and COX1.

15. The method of claim 1 , wherein a subject has a risk of having or has a polyp if the polyp biomarker panel measurements show a change in expression of a polyp biomarker of at least 15% compared to a control subject population.

16. The method of 1 , wherein the polyp biomarker panel based upon a biopsy comprises one or more of the biomarkers Groα, CXCR2, and PPARδ.

17. The method of claim 1 , wherein a subject has a risk of having or has a colorectal cancer if the cancer biomarker panel measurements show a change in expression of a cancer biomarker of at least 15% compared to a control subject population.

18. The method of claim 1 , comprising measuring a polyp or cancer biomarker panel and comparing the measurements to a control wherein a change relative to the control is indicative that the subject has or is at risk of developing a polyp or cancerous lesion.

19. The method of claim 18 , wherein a subject that is identified as having a predisposition or risk of developing a polyp is monitored for a cancer biomarker panel.

20. The method of claim 18 , wherein the cancer biomarker panel is obtained by swab in the absence of an RNA protection cocktail.

21. The method of claim 20 , wherein the cancer biomarker panel based upon a swab in the absence of an RNA protection cocktail comprises one or more of the biomarkers PPARα, CXCR2, cMyc and CD44.

22. The method of claim 20 , wherein a subject has a risk of having or has a colorectal cancer if the cancer biomarker panel measurements show a change in expression of a cancer biomarker of at least 15% compared to a control subject population.

23. The method of claim 18 , wherein the cancer biomarker panel based upon a swab is obtained in the presence of an RNA protection cocktail.

24. The method of claim 23 , wherein cancer biomarker panel based upon a swab in the presence of an RNA protection cocktail comprises one or more of the biomarkers COX2 and IL-8.

25. The method of claim 1 , wherein the polyp biomarker panel based upon a swab comprises one or more of the biomarkers CD44, PPARγ, and COX1.

26. The method of claim 25 , wherein a subject has a risk of having or has a polyp if the polyp biomarker panel measurements show a change in expression of a polyp biomarker of at least 15% compared to a control subject population.

27. The method of 1 , wherein the polyp biomarker panel based upon a biopsy comprises one or more of the biomarkers Groα, CXCR2, and PPARδ.

28. The method of claim 1 , wherein measuring FHSH biomarker panel, a polyp biomarker panel, a rectal bleeding biomarker panel, a cancer biomarker panel or any combination thereof, is carried out by using an array comprising oligonucleotides that are biomarkers for FHSH, polyp, rectal bleeding, cancer, or any combination thereof.

29. The method of claim 28 , wherein the array comprises at least biomarkers for Groα, CD44, and COX1.

Assignments (3)
CHANGE OF NAME Recorded Apr 27, 2016
From: SUTTER WEST BAY HOSPITALS
To: SUTTER BAY HOSPITALS
Reel/Frame 038542/0160 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 13, 2015
From: SUTTER WEST BAY HOSPITALS
To: LEE, NANCY M.
Reel/Frame 036319/0855 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 21, 2010
From: LEE, NANCY M.
To: SUTTER WEST BAY HOSPITALS
Reel/Frame 024568/0937 →
Continuity (2)
Provisional Application 60952194 · Jul 26, 2007
Related Publication 20100261221A1 · Oct 14, 2010