Is Your Patient Eligible?

Prostate cancer patients Genomic Prostate Score 

Your patients with clinically low- or intermediate-risk prostate cancer might be candidates for the Oncotype DX Genomic Prostate Score (GPS) test.

Eligibility

The Oncotype DX GPS assay is for men who have:

  • Had a prostate biopsy within the last three years.
  • Not started definitive treatment (e.g. surgery or radiation).
  • National Comprehensive Cancer Network® (NCCN®) very low-, low-, or intermediate-risk disease.


NCCN Risk Stratification
RISK GROUP
CLINICAL / PATHOLOGIC FEATURES
Very Low
    Has all of the following:
  • T1c
  • Grade Group 1
  • PSA <10 ng/mL
  • Fewer than 3 prostate biopsy fragments/cores positive, ≤50% cancer in each fragment/coree
  • PSA density <0.15 ng/mL/g
Low
    Has all of the following but does not qualify for very low risk:
  • T1-T2a
  • Grade Group 1
  • PSA <10 ng/mL
Intermediate
    Has all of the following:
  • No high-risk group features
  • No very-high-risk group features
  • Has one or more intermediate risk factors (IRF):
    • T2b-T2c
    • Grade Group 2 or 3
    • PSA 10-20 ng/mL
Favorable intermediate
Has all of the following:
  • 1 IRF
  • Grade Group 1 or 2
  • <50% biopsy cores positivee
Unfavorable intermediate
Has one or more of the following:
  • 2 or 3 IRFs
  • Grade Group 3
  • ≥50% biopsy cores positivee
Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2020. ©2020 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org. The NCCN Guidelines® are a work in progress that may be refined as often as new significant data becomes available.

When to order the test

Because the goal of the Oncotype DX GPS assay is to facilitate management planning for prostate cancer patients, the best time to order the test is shortly after biopsy and before initial treatment decisions have been made. Ordering is easy, and the test can be run on a small sample from a recent biopsy.



Insurance and financial assistance

The Oncotype DX GPS test is covered by Medicare (for NCCN very low-, low- and intermediate-risk cancer). Private insurance coverage varies. To help patients navigate insurance and other payment options for Oncotype DX testing, Exact Sciences offers the Genomic Access Program (GAP) and detailed information about financial assistance. Email Customer Service or call us 866-ONCOTYPE (866-662-6897).




REFERENCES

e. An ultrasound- or MRI- or DRE-targeted lesion that is biopsied more than once demonstrates cancer (regardless of percentage core involvement or number of cores involved) counts as a single positive core.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V2.2020. ©National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed June 1, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. NCCN and NCCN Guidelines are registered trademarks of the National Comprehensive Cancer Network. NCCN does not endorse any therapy or product.

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