About the Oncotype DX Genomic Prostate Score Assay

The Oncotype DX Genomic Prostate Score (GPS) assay is the only genomic assay designed for men with clinically low- or intermediate-risk cancer to help make treatment decisions at the time of diagnosis. The assay analyzes prostate cancer gene activity to predict disease aggressiveness.

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.
  • Measuring biology through the expression of 17 genes across four important genetic pathways and, in conjunction with clinical risk factors, predicts the likelihood of adverse pathology, prostate cancer death, and metastasis at 10 years.1
 

How do you use the short-term GPS™ report endpoint, Adverse Pathology?

Doctors Scott Sellinger (Advanced Urology Institute) and Brian Helfand (NorthShore Medical Group) explain why adverse pathology is important in helping patients decide next steps in early-stage prostate cancer.

 

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+). It is the most important and actionable endpoint when individualizing patient management.


Low High Risk


Long-term endpoints predict future tumor behavior to ease patient concerns and offer reassurance3,7

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 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

ASCO’s expert panel endorses tissue-based biomarkers, including the Oncotype DX assay, 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 levels, Gleason score, anatomic stage, and NCCN® risk classification), 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 5,000 patients.1-14 The results from the assay refine risk assessment, help guide treatment decisions, and potentially impact patient quality of life. For example, the results might give a low- or favorable intermediate-risk patient the additional confidence he needs 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.2.2020.
  16. Eggener et al. J Clin Oncol. 2019.

b. DOI: 10.1016/j.eururo.2017.09.013
National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN. NCCN does not endorse any product or therapy.

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