Oncotype DX: The Only Genomic Test Developed Specifically for Clinically Low-Risk Prostate Cancer Patients

Be Confident When Deciding between Active Surveillance or Immediate Treatment

Oncotype DX Prolaris Decipher Biopsy1
Developed and Validated specifically for clinically low-risk patients ✓︎ NO NO
Provides Additional Information by predicting if the cancer has grown outside the prostate2* ✓︎ NO NO
Predicts Biochemical Recurrence (BCR) after surgery ✓︎ ✓︎ NO
Medicare Reimbursement for qualified Medicare patients ✓︎ ✓︎ NO
Recognized in the NCCN Guidelines 2016 v3 ✓︎ ✓︎ NO
Predicts the risk of death AND metastasis 10 years after surgery ✓︎ ✓︎ ✓︎

The Oncotype DX prostate cancer test was developed to be used for men recently diagnosed with clinically low-risk prostate cancer, after their biopsy and before they make their treatment decision. Although biopsies provide important information, they may not provide an accurate picture of the tumor extent and aggressiveness. Biopsies are limited and sample only a small fraction of the tumor. Additional information may help estimate an individual patient’s risk with more confidence.

Developed and validated for clinically low-risk prostate cancer patients, the Oncotype DX Genomic Prostate Score (GPS) test assesses the activity of specific cancer-related genes from the biopsy to better characterize an individual patient’s tumor. The GPS result is reported as a number between 0 and 100 that is unique to each man, reflecting a range of prostate cancer biology. The lower your GPS result is, the more likely your tumor is organ confined and low grade. A high GPS result would indicate greater likelihood of high grade disease.

Giving you insight to help individualize your treatment plan, the additional information provided by your GPS result will help predict whether your likelihood of low grade disease is lower, higher, or consistent with your clinical information. The Oncotype DX prostate cancer test has also been validated as a strong independent predictor of biochemical recurrence (a rise in PSA) following surgery. The Oncotype DX Prostate cancer test is also recognized in the NCCN oncology guidelines. Medicare has established coverage for the Oncotype DX prostate cancer test for very low and low NCCN risk criteria patients.

The Oncotype DX Genomic Prostate Score test is a powerful clinical tool that helps determine if your prostate cancer is low risk. By providing additional information about your tumor, this information helps you and your doctor confidently choose an individualized treatment plan that’s right for you based on your overall health, lifestyle, and doctor’s assessment.

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NCCN Guidelines

Risk Category Criteria
Very Low
  • Stage T1c
  • Gleason Score 6 or less
  • No more than 2 cores of cancer
  • <50% of core involved with cancer
  • PSA less than 10 ng/mL
  • PSA density less than 0.15 ng/mL/mL
Low
  • Stage T1c or T2a
  • PSA less than 10 ng/mL
  • Gleason Score 6 or less
Intermediate3 Must meet ONE of the following:
  • Gleason Score ≤ 3+3
    AND
  • PSA 10-20 ng/mL
    AND/OR
  • Clinical stage T2b-T2c
OR
  • Gleason Score = 3+4
    AND
  • PSA ≤20 ng/mL
    AND
  • Clinical stage T1c-T2c
Important: Must have PSA <20 ng/mL, Clinical Stage ≤T2c

1 Prolaris is a registered trademark of Myriad Genetics Inc. Decipher Biopsy is a trademark of GenomeDX Biosciences. Please refer to these manufacturers directly for more information.
2 Klein et al, Eur Urol 2014; Cuzick et al, Br. J. Cancer 2012; Klein et al, Urology, April 2016.
3Select intermediate risk patients are eligible for the Oncotype DX Genomic Prostate Score.
*In this context, prostate cancer growing outside of the prostate refers to pT3 disease (non-organ confined) cancer, not necessarily to cancer that has spread to the lymph nodes.