IP Library Granted Patent US 8,034,565
Granted Patent B2
US 8,034,565 · App. 12/478,632 · Granted Oct 11, 2011

Gene expression markers for breast cancer prognosis

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Quick Facts
Patent No.
US 8,034,565
App. No.
12/478,632
Granted
Oct 11, 2011
Kind
B2
Abstract

The present invention provides gene sets the expression of which is important in the diagnosis and/or prognosis of breast cancer.

Claims (25)

1. A method of predicting the likelihood of long-term survival of a breast cancer patient without the recurrence of breast cancer, comprising:

determining an expression level of an RNA transcript of KRT14, or its expression product, in a breast cancer tumor sample obtained from the patient;

normalizing said expression level to obtain a normalized expression level of KRT14;

wherein increased normalized expression level of KRT14 indicates an increased likelihood of long-term survival without breast cancer recurrence.

2. The method of claim 1 , further comprising:

determining an expression level of at least one RNA transcript or its expression product in a breast cancer tumor sample obtained from the patient, wherein the at least one RNA transcript is the transcript of a gene selected from the group consisting of: TP53BP2, GRB7, PR, CD68, Bcl2, IRS1, CTSL, EstR1, Chk1, IGFBP2, BAG1, CEGP1, STK15, GSTM1, FHIT, RIZ1, AIB1, SURV, BBC3, IGF1R, p27, GATA3, ZNF217, EGFR, CD9, MYBL2, HIF1α, pS2, ErbB3, TOP2B, MDM2, RAD51C, KRT19, TS, Her2, KLK10, β-Catenin, γ-Catenin, MCM2, PI3KC2A, IGF1, TBP, CCNB1, FBXO5, and DR5;

normalizing said expression level of the at least one RNA transcript or its expression product to obtain a normalized expression level of the at least one RNA transcript or its expression product;

wherein increased normalized expression level of GRB7, CD68, CTSL, Chk1, AIB1, CCNB1, MCM2, FBXO5, Her2, STK15, SURV, EGFR, MYBL2, HIF1α, and TS indicates a decreased likelihood of long-term survival without breast cancer recurrence, and increased normalized expression level of TP53BP2, PR, Bcl2, EstR1, IGFBP2, BAG1, CEGP1, KLK10, β-Catenin, γ-Catenin, DR5, PI3KCA2, RAD51C, GSTM1, FHIT, RIZ1, BBC3, TBP, p27, IRS1, IGF1R, GATA3, ZNF217, CD9, pS2, ErbB3, TOP2B, MDM2, IGF1, and KRT19 indicates an increased likelihood of long-term survival without breast cancer recurrence.

3. The method of claim 1 , wherein the breast cancer is invasive breast carcinoma.

4. The method of claim 1 , wherein the breast cancer tumor sample is a fixed, wax-embedded tissue specimen.

5. The method of claim 1 , wherein the breast cancer tumor sample is core biopsy tissue or fine needle aspirated cells.

6. The method of claim 1 , wherein the breast cancer is estrogen-receptor negative breast cancer.

7. The method of claim 1 , wherein the expression level is determined by quantitative reverse-transcription polymerase chain reaction (qRT-PCR).

8. The method of claim 1 , wherein the expression level is determined by immunohistochemistry or proteomics technology.

9. The method of claim 1 , further comprising creating a report based on the normalized expression level of KRT14.

10. The method of claim 9 , wherein said report includes a prediction of the likelihood of long-term survival of the patient without recurrence of breast cancer.

11. A method of preparing a personalized genomics profile for a breast cancer patient, comprising:

(a) subjecting RNA extracted from breast tissue obtained from the patient to gene expression analysis;

(b) determining an expression level of an RNA transcript of KRT14, or its expression product, wherein the expression level is normalized against the expression level of at least one reference gene to obtain normalized data or the expression levels in a breast cancer reference tissue set; and

(c) creating a report summarizing the normalized data obtained by said gene expression analysis, wherein said report includes a prediction of the likelihood of long-term survival of the patient without recurrence of breast cancer.

12. The method of claim 11 , wherein said breast tissue comprises breast cancer cells.

13. The method of claim 11 , wherein said breast tissue is obtained from a fixed, wax-embedded sample.

14. The method of claim 11 , wherein said breast tissue is obtained from core biopsy tissue or fine needle aspirated cells.

15. The method of claim 11 , wherein the expression level is determined by quantitative reverse-transcription polymerase chain reaction (qRT-PCR).

16. The method of claim 11 , wherein the expression level is determined by immunohistochemistry or proteomics technology.

Assignments (6)
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 Sep 7, 2010
From: RUSH UNIVERSITY MEDICAL CENTER
To: GENOMIC HEALTH, INC.
Reel/Frame 024949/0590 →
CHANGE OF NAME Recorded Jan 14, 2010
From: RUSH-PRESBYTERIAN-ST. LUKE'S MEDICAL CENTER
To: RUSH UNIVERSITY MEDICAL CENTER
Reel/Frame 023788/0532 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 10, 2009
From: SHAK, STEVE; BAKER, JOFFRE B.; CRONIN, MAUREEN T.
To: GENOMIC HEALTH, INC.
Reel/Frame 023499/0238 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 10, 2009
From: COBLEIGH, MELODY A.
To: RUSH-PRESBYTERIAN-ST. LUKE'S MEDICAL CENTER
Reel/Frame 023499/0243 →