About the Oncotype DX Genomic Prostate Score Assay

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The Oncotype DX Genomic Prostate Score (GPS) assay is a genomic assay designed for men with low-, intermediate-, and high-risk localized prostate cancer to help guide treatment decisions at the time of diagnosis.1-18 The assay analyzes prostate cancer gene activity to predict disease aggressiveness to help refine risk assessment, as well as provides clinically meaningful endpoints.

With two tailored reports, the GPS assay provides useful information for when active surveillance may be an appropriate decision, as well as risk estimates to help inform your treatment decisions for higher risk patients.18

NCCN+GPS:Very LowLow Favorable Intermediate

See How These Doctors Used the GPS Report to Decide When to Treat

The GPS report provides additional information to help when deciding on whether to pursue active surveillance or more aggressive treatment options.


Overview of the redesigned low-risk report for the Oncotype DX GPS Assay

Dr. Daniel Shoskes, MD, (Field Medical Director of Urologic Oncology Medical Affairs) provides an overview of the redesigned Oncotype DX® GPS™ report for clinically low-risk prostate cancer.


Detailed description of the Oncotype DX GPS low-risk report

Dr. Daniel Shoskes, MD, (Field Medical Director of Urologic Oncology Medical Affairs) shares details of the redesigned low-risk report for the Oncotype DX GPS Assay.

NCCN+GPS:Unfavorable IntermediateHigh

Learn How the GPS Report Can Help Doctors Decide How to Treat

The GPS report provides information to help select treatment intensity.


Introduction to the Clinically High-Risk Report for the Oncotype DX GPS Assay

Dr. Rick Baehner discusses the new Oncotype DX GPS assay report for clinically high-risk prostate cancer patients.


 

The Oncotype DX GPS assay provides more specific and individualized information about prostate cancer aggressiveness by:

  • Providing a GPS result ranging from 0-100 that corresponds to the biologic aggressiveness of the tumor.
  • The 17-gene signature includes 12 active genes across four important genetic groups and 5 reference genes to ensure the quality of the tested tissues. In conjunction with clinical risk factors, the Oncotype DX GPS assay predicts the likelihood of adverse pathology, prostate cancer death and metastasis within 10 years, as well as biochemical recurrence within 3 years.1-3,18

Provides crucial endpoints with actionable data to help address the needs of each patient

Adverse Pathology

Predicts the risk of aggressive disease at the time of biopsy1,2

Adverse pathology is the presence of high-grade (Gleason Score ≥4 + 3) and/or non-organ-confined disease (pT3+) at the time of biopsy. It is the most important and actionable endpoint when individualizing patient management.

Why was adverse pathology chosen as the endpoint when you launched the test back in 2013?

Dr. Rick Baehner, MD, (Chief Medical Officer of Precision Oncology) discusses why adverse pathology was chosen as an endpoint when launching the Oncotype DX GPS Assay.


When and How to Treat Chart

Biochemical Recurrence

Predicts the likelihood of an increasing PSA level within 3 years of radical prostatectomy18

Biochemical recurrence is the result of two successive PSA levels >0.2ng/mL or initiation of salvage therapy due to a rising PSA.

Biochemical Recurrence

Metastasis and Prostate Cancer Death

Long-term endpoints predict future tumor behavior to ease patient concerns and offer reassurance3,17

The Oncotype DX GPS assay is proven to be an independent predictor of clinical risk and provides a risk estimate of:


GPS Risk within 10 years

Included within guidelines


NCCN Clinical Practice Guidelines in Oncology® (NCCN Guidelines®) include the GPS assay as a Category 2A molecular testing option for consideration in prostate cancer patients with low- and favorable intermediate-risk disease (life expectancy >10 years).15

The ASCO expert panel endorses tissue-based biomarkers to be used as part of the patient’s overall testing strategy when trying to decide between active surveillance and immediate treatment.16

See the benefits of integrating the test into your practice

The impact of the Oncotype DX GPS assay on treatment planning has been demonstrated in multiple clinical utility studies.

Prospective study

Assessed changes in urologists’ treatment recommendations pre- and post-Oncotype DX GPS results. This decision-impact study demonstrated a 26% absolute change in management recommendations. Physician confidence improved in 85% of cases.7

Retrospective Study

Compared 6-month management received in clinically low-risk patients with and without the Oncotype DX GPS results. This chart-review analysis revealed a 56% relative increase in the number of patients on active surveillance/watchful waiting at 6 months post-diagnosis when GPS testing was added to standard decision making tools.8


Explaining risk to patients

The Oncotype DX GPS assay provides meaningful information on the aggressiveness of the tumor that, when combined with clinical and pathologic features PSA, helps when discussing management options with patients. The GPS report is a patient-friendly resource that facilitates discussions by consolidating key prostate cancer characteristics in a single document for ease of reference during management conversations.

Clear advantages for your patients

The Oncotype DX GPS assay has been developed and studied in over 9,000 patients.1-14,17,18 The results from the assay refine risk assessment and help inform treatment decisions. For example, the test might give a low- or favorable intermediate-risk patient the additional confidence to pursue active surveillance, delaying or even completely avoiding the side effects of more aggressive treatment options like prostatectomy or radiation therapy.

REFERENCES

  1. Klein et al. Eur Urol. 2014.
  2. Cullen et al. Eur Urol. 2015.
  3. Van Den Eeden et al. Eur Urol. 2017.
  4. Eure et al. AUA 2017.
  5. Brand et al. Urology. 2016.
  6. Knezevic et al. BMC Genomics. 2013.
  7. Badani et al. Urol Pract. 2015.
  8. Dall'Era et al. Urol Pract. 2015.
  9. Lynch et al. Am J Manage Care 2018.
  10. Albala et al. Rev Urol. 2016.
  11. Bonham et al. USCAP 2016.
  12. Salmasi et al. J Urol. 2018.
  13. Eure et al. Urology. 2017.
  14. Leapman et al. PloS One. 2017.
  15. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. V.2.2021.
  16. Eggener et al. J Clin Oncol. 2019.
  17. Cullen et al. Urology. 2020.
  18. Data on file.

b. DOI: 10.1016/j.eururo.2017.09.013
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology. 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.

American Society of Clinical Oncology (ASCO) and ASCO are registered trademarks of ASCO; ASCO do not endorse any product or therapy.

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