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
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 at 10 years, metastasis at 10 years, as well as biochemical recurrence at 3 years.1-3,18
Provides crucial endpoints with actionable data to help address the needs of each patient
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.
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.
Predicts the likelihood of an increasing PSA level within 3 years of treatment18
Biochemical recurrence is the result of two successive PSA levels >0.2ng/mL or initiation of salvage therapy due to a rising PSA.
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:
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.
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
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 5,000 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.