IP Library Granted Patent US 9,551,034
Granted Patent B2
US 9,551,034 · App. 12/987,023 · Granted Jan 24, 2017

Method to use gene expression to determine likelihood of clinical outcome of renal cancer

Inventors: Wayne Cowens (Tiburon, CA); Steven Shak (Hillsborough, CA); Audrey Goddard (San Francisco, CA); Dejan Knezevic (Palo Alto, CA); Joffre Baker (Montara, CA); Michael C. Kiefer (Clayton, CA); Tara Maddala (Sunnyvale, CA); Frederick L. Baehner (San Francisco, CA)
Assignee: Genomic Health, Inc.
C12Q1/6886G01N33/57438C12Q2600/112C12Q2600/118C12Q2600/158
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Quick Facts
Patent No.
US 9,551,034
App. No.
12/987,023
Granted
Jan 24, 2017
Kind
B2
Abstract

The present disclosure provides gene and gene sets, the expression of which is important in the classification and/or prognosis of cancer, in particular of renal cell carcinoma.

Claims (27)

1. A method for determining a likelihood of recurrence of renal cell carcinoma for a human patient comprising:

(a) measuring, in a renal cell carcinoma sample obtained from the human patient a level of an RNA transcript of PPAP2B, wherein the measuring is performed using polymerase chain reaction (PCR) with a polynucleotide comprising the sequence of SEQ ID NO: 545 and a polynucleotide comprising the sequence of SEQ ID NO: 1277 as PCR primers and a polynucleotide comprising the sequence of SEQ ID NO: 2009 as a probe to detect PPAP2B polynucleotides produced by PCR;

(b) normalizing the level of the RNA transcript of PPAP2B against at least one reference RNA transcript from the sample to obtain a normalized PPAP2B expression level;

(c) comparing the normalized PPAP2B expression level to a normalized PPAP2B expression level obtained from a renal cell carcinoma sample from a human patient with recurrent renal cell carcinoma; and

(d) determining a decreased likelihood for recurrence of renal cell carcinoma for the human patient if the normalized PPAP2B expression level is increased compared to the normalized PPAP2B expression level obtained from the renal cancer sample from the human patient with recurrent renal cell carcinoma.

2. The method of claim 1 , further comprising generating a report based on the normalized PPAP2B expression level.

3. The method of claim 1 , further comprising calculating a score estimating the likelihood that the patient will have a recurrence of renal cell carcinoma based on the normalized PPAP2B expression level.

4. The method of claim 3 , further comprising generating a report based on the score.

5. The method of claim 1 , further comprising wherein the renal cell carcinoma sample is a paraffin-embedded sample.

6. The method of claim 1 , wherein the renal cell carcinoma sample is a frozen sample.

7. A method for determining presence of necrosis in a renal cell carcinoma sample obtained from a human patient, comprising:

(a) measuring, in a renal cell carcinoma sample obtained from the human patient a level of an RNA transcript of PPAP2B, wherein the measuring is performed using polymerase chain reaction (PCR) with a polynucleotide comprising the sequence of SEQ ID NO: 545 and a polynucleotide comprising the sequence of SEQ ID NO: 1277 as PCR primers and a polynucleotide comprising the sequence of SEQ ID NO: 2009 as a probe to detect PPAP2B polynucleotides produced by PCR;

(b) normalizing the level of the RNA transcript of PPAP2B against at least one reference RNA transcript from the sample to obtain a normalized PPAP2B expression level;

(c) comparing the normalized PPAP2B expression level to a normalized PPAP2B expression level obtained from a renal cell carcinoma sample without necrosis; and

(d) determining the presence of necrosis in the renal cell carcinoma sample if the normalized PPAP2B expression level is decreased compared to the normalized PPAP2B expression level obtained from the renal cancer sample without necrosis.

8. The method of claim 7 , wherein the renal cell carcinoma sample is a paraffin-embedded sample.

9. The method of claim 7 , wherein the renal cell carcinoma sample is a frozen sample.

10. A method for determining a likelihood of recurrence of renal cell carcinoma for a human patient, comprising:

extracting RNA from a renal cell carcinoma sample obtained from the human patient;

reverse transcribing an RNA transcript of PPAP2B to produce a cDNA of PPAP2B;

amplifying, using polymerase chain reaction (PCR), the cDNA of PPAP2B to produce an amplicon of the RNA transcript of PPAP2B, wherein the PCR uses a polynucleotide comprising the sequence of SEQ ID NO:545 and a polynucleotide comprising the sequence of SEQ ID NO: 1277 as primers;

assaying a level of the amplicon of the RNA transcript of PPAP2B with a polynucleotide comprising the sequence of SEQ ID NO: 2009;

normalizing the amplicon level of the RNA transcript of PPAP2B against an amplicon level of at least one reference RNA transcript in the renal cell carcinoma sample to provide normalized amplicon level of PPAP2B,

comparing the normalized amplicon level of PPAP2B from the human patient to a normalized amplicon level of PPAP2B from a renal cell carcinoma sample from a human patient with recurrent renal cell carcinoma; and

determining that the human patient has a decreased likelihood of recurrence of renal cell carcinoma if the normalized amplicon level of PPAP2B from the human patient is increased compared to the normalized PPAP2B expression level obtained from the renal cell carcinoma sample from the human patient with recurrent renal cell carcinoma.

11. The method of claim 10 , further comprising wherein the renal cell carcinoma sample is a paraffin-embedded sample.

12. The method of claim 10 , wherein the renal cell carcinoma sample is a frozen sample.

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 Feb 4, 2011
From: COWENS, WAYNE; SHAK, STEVEN; GODDARD, AUDREY; KNEZEVIC, DEJAN; BAKER, JOFFRE; KIEFER, MICHAEL C.; MADDALA, TARA; BAEHNER, FREDERICK L.
To: GENOMIC HEALTH, INC.
Reel/Frame 025748/0622 →
Continuity (3)
Provisional Application 61294038 · Jan 11, 2010
Provisional Application 61346230 · May 19, 2010
Related Publication 20110171633A1 · Jul 14, 2011