IP Library Granted Patent US 8,029,995
Granted Patent B2
US 8,029,995 · App. 12/911,532 · Granted Oct 4, 2011

Gene expression markers for colorectal cancer prognosis

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Quick Facts
Patent No.
US 8,029,995
App. No.
12/911,532
Granted
Oct 4, 2011
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 a normalized expression level of an RNA transcript of MYBL2, or an expression product 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 level of an RNA transcript of MYBL2, or an expression product thereof, wherein said normalized expression level of an RNA transcript of MYBL2, or an expression product thereof, is 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 Ki-67, CMYC, BGN, 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 each of Ki-67 and CMYC is positively correlated with an increased likelihood of a positive clinical outcome.

3. The method of claim 1 , wherein said normalized expression level of an RNA transcript of MYBL2 is determined using a PCR-based method.

4. The method of claim 1 , wherein said normalized expression level of an RNA transcript of MYBL2, or an expression product thereof, is 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 level of an RNA transcript of MYBL2, or an expression product 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 level of an RNA transcript of MYBL2, or an expression product thereof, wherein said normalized expression level of an RNA transcript of MYBL2, or an expression product thereof, is 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, Ki-67, CMYC, 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 each of Ki-67 and CMYC is negatively correlated with an increased likelihood of recurrence of colorectal cancer.

11. The method of claim 9 , wherein said normalized expression level of an RNA transcript of MYBL2 is 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 level of an RNA transcript of MYBL2, or an expression product thereof, is 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 025198/0893 →