IP Library Granted Patent US 10,260,104
Granted Patent B2
US 10,260,104 · App. 14/887,605 · Granted Apr 16, 2019

Method for using gene expression to determine prognosis of prostate cancer

Inventors: Steven Shak (Hillsborough, CA); Frederick L. Baehner (San Francisco, CA); Tara Maddala (Sunnyvale, CA); Mark Lee (Los Altos Hills, CA); Robert J. Pelham (Belmont, CA); Wayne Cowens; Diana Cherbavaz (San Francisco, CA); Michael C. Kiefer (Walnut Creek, CA); Michael Crager (Menlo Park, CA); Audrey Goddard (San Francisco, CA); Joffre B. Baker (Montara, CA)
Assignee: Genomic Health, Inc.
C12Q1/6886G06F19/00C12Q2600/118C12Q2600/158C12Q2600/178
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,260,104
App. No.
14/887,605
Granted
Apr 16, 2019
Kind
B2
Abstract

The present disclosure includes assays that involve measurement of expression levels of prognostic biomarkers, or co-expressed biomarkers, from a biological sample obtained from a prostate cancer patient, and analysis of the measured expression levels to provide information concerning the likely prognosis for the patient, and likelihood that the patient will have a recurrence of prostate cancer, or to classify the tumor by likelihood of clinical outcome or TMPRSS2 fusion status.

Claims (15)

1. A method of analyzing the expression of RNA transcripts of genes in a human prostate cancer patient, comprising:

obtaining a prostate tumor tissue sample from a human prostate cancer patient;

extracting RNA from the tissue sample;

reverse transcribing RNA transcripts of a group of genes consisting of: BGN, COL1A1, SFRP4, FLNC, GSN, GSTM2, TPM2, AZGP1, KLK2, FAM13C, SRD5A2, and TPX2, and at least one reference gene, to produce cDNAs from the RNA transcripts, wherein a reference gene is a gene that does not exhibit a significantly different RNA expression level in cancerous prostate tissue compared to non-cancerous prostate tissue; and

amplifying the cDNAs to produce amplicons from the cDNAs for determination of expression levels of the RNA transcripts.

2. The method of claim 1 , wherein the at least one reference gene comprises one or more of AAMP, ARF1, ATP5E, CLTC, EEF1A1, GPS1, GPX1, and PGK1.

3. The method of claim 1 , wherein the at least one reference gene is selected from the group consisting of AAMP, ARF1, ATP5E, CLTC, EEF1A1, GPS1, GPX1, and PGK1.

4. The method of claim 1 , wherein the tissue sample has a positive TMPRSS2 fusion status.

5. The method of claim 1 , wherein the tissue sample has a negative TMPRSS2 fusion status.

6. The method of claim 1 , wherein the patient has early-stage prostate cancer.

7. The method of claim 1 , wherein the tissue sample comprises prostate tumor tissue with the primary Gleason pattern for the patient's prostate tumor.

8. The method of claim 1 , wherein the tissue sample comprises prostate tumor tissue with the highest Gleason pattern for the patient's prostate tumor.

9. The method of claim 1 , wherein the tissue sample comprises non-tumor prostate tissue.

10. The method of claim 1 , wherein the patient is receiving active surveillance treatment.

11. The method of claim 1 , wherein the at least one reference gene consists of from 1 to 6 reference genes.

Assignments (3)
SECURITY INTEREST Recorded May 1, 2024
From: MDXHEALTH SA
To: ORC SPV LLC
Reel/Frame 067284/0082 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 3, 2022
From: GENOMIC HEALTH, INC.
To: MDXHEALTH SA
Reel/Frame 060705/0152 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 25, 2022
From: SHAK, STEVEN; BAEHNER, FREDERICK L.; MADDALA, TARA; LEE, MARK; PELHAM, ROBERT J.; COWENS, WAYNE; CHERBAVAZ, DIANA; KIEFER, MICHAEL C.; CRAGER, MICHAEL; GODDARD, AUDREY; BAKER, JOFFRE B.
To: GENOMIC HEALTH, INC.
Reel/Frame 060012/0931 →
Continuity (5)
Continuation 13190391 · Jul 25, 2011
Provisional Application 61368217 · Jul 27, 2010
Provisional Application 61414310 · Nov 16, 2010
Provisional Application 61485536 · May 12, 2011
Related Publication 20160097105A1 · Apr 7, 2016