IP Library Granted Patent US 8,273,537
Granted Patent B2
US 8,273,537 · App. 12/911,519 · Granted Sep 25, 2012

Gene expression markers for colorectal cancer prognosis

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Quick Facts
Patent No.
US 8,273,537
App. No.
12/911,519
Granted
Sep 25, 2012
Kind
B2
Abstract

A method of predicting clinical outcome in a subject diagnosed with colorectal cancer comprising determining evidence of the expression of one or more predictive RNA transcripts or their expression products in a biological sample of cancer cells obtained from the subject.

Claims (24)

1. A method of predicting clinical outcome for a human subject diagnosed with colorectal cancer following surgical resection of said cancer, comprising:

determining normalized expression levels of RNA transcripts of CMYC and Ki-67, or expression products thereof, in a biological sample comprising cancer cells obtained from said human subject, and;

predicting the likelihood of a positive clinical outcome for said human subject based on said normalized expression levels of RNA transcripts of CMYC and Ki-67, or expression products thereof, wherein said normalized expression levels of RNA transcripts of CMYC and Ki-67, or expression products thereof, are positively correlated with an increased likelihood of a positive clinical outcome.

2. The method of claim 1 , further comprising determining a normalized expression level of an RNA transcript, or an expression product thereof, of one or more of BGN, MYBL2, FAP, INHBA, and GADD45B in the biological sample;

wherein said normalized expression level of each of BGN, FAP, INHBA, and GADD45B is negatively correlated with an increased likelihood of a positive clinical outcome; and

wherein said normalized expression level of MYBL2 is positively correlated with an increased likelihood of a positive clinical outcome.

3. The method of claim 1 , wherein said normalized expression levels of RNA transcripts of CMYC and Ki-67 are determined using a PCR-based method.

4. The method of claim 1 , wherein said normalized expression levels of RNA transcripts of CMYC and Ki-67, or expression products thereof, are normalized relative to the expression level of an RNA transcript, or an expression product thereof, of at least one reference gene.

5. The method of claim 1 , wherein said clinical outcome is expressed in terms of Recurrence-Free Interval (RFI), Overall Survival (OS), Disease-Free Survival (DFS), or Distant Recurrence-Free Interval (DRFI).

6. The method of claim 1 , wherein said colorectal cancer is Dukes B (stage II) or Dukes C (stage III) colorectal cancer.

7. The method of claim 1 , wherein said colorectal cancer is Dukes B (stage II) or Dukes C (stage III) colon cancer.

8. The method of claim 1 , further comprising the step of creating a report summarizing said prediction.

9. A method of predicting in a human subject diagnosed with Dukes B (stage II) or Dukes C (stage III) colorectal cancer a likelihood of recurrence of colorectal cancer following surgical resection of said cancer, comprising:

determining the normalized expression levels of RNA transcripts of CMYC and Ki-67, or expression products thereof, in a biological sample comprising cancer cells obtained from said human subject, and;

predicting the likelihood of recurrence of colorectal cancer for the human subject based on the normalized expression levels of RNA transcripts of CMYC and Ki-67, or expression products thereof, wherein said normalized expression levels of RNA transcripts of CMYC and Ki-67, or expression products thereof, are negatively correlated with an increased likelihood of recurrence of colorectal cancer.

10. The method of claim 9 , further comprising determining a normalized expression level of an RNA transcript, or an expression product thereof, of one or more of BGN, MYBL2, FAP, INHBA, and GADD45B in the biological sample;

wherein said normalized expression level of each of BGN, FAP, INHBA, and GADD45B is positively correlated with an increased likelihood of recurrence of colorectal cancer; and

wherein said normalized expression level of MYBL2 is negatively correlated with an increased likelihood of recurrence of colorectal cancer.

11. The method of claim 9 , wherein said normalized expression levels of RNA transcripts of CMYC and Ki-67 are determined using a PCR-based method.

12. The method of claim 9 , wherein if said likelihood of recurrence of colorectal cancer is increased, said human subject is subjected to further therapy following said surgical resection.

13. The method of claim 12 , wherein said further therapy is chemotherapy and/or radiation therapy.

14. The method of claim 9 , further comprising the step of creating a report summarizing said prediction.

15. The method of claim 9 , wherein said normalized expression levels of RNA transcripts of CMYC and Ki-67, or expression products thereof, are normalized relative to the expression level of an RNA transcript, or an expression product thereof, of at least one reference gene.

16. The method of claim 9 , wherein said colorectal cancer is Dukes B (stage II) or Dukes C (stage III) colon cancer.

Assignments (3)
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENT RIGHTS (REEL/FRAME 69898/0380) Recorded Mar 27, 2026
From: JPMORGAN CHASE BANK, N.A.
To: GENOMIC HEALTH, INC.
Reel/Frame 075294/0821 →
PATENT SECURITY AGREEMENT Recorded Jan 14, 2025
From: GENOMIC HEALTH, INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 069898/0380 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 26, 2010
From: COWENS, WAYNE; BAKER, JOFFRE; CLARK, KIM; HACKETT, JAMES; WATSON, DREW; PAIK, SOONMYUNG
To: GENOMIC HEALTH, INC.; NSABP FOUNDATION, INC.
Reel/Frame 025198/0901 →