Developed, clinically validated, and studied in over 9,000 patients1-19
>9,000
Patients1-19
The Oncotype DX GPS test was specifically designed to guide treatment decisions in patients with clinically low- or intermediate-risk prostate cancer. Over 9,000 patients have been included in development studies, clinical validation studies, and clinical utility studies.1-19
Clinical validation studies
The clinical validation studies for the Oncotype DX Genomic Prostate Score (GPS) test were prospectively designed studies of archival tissue from a large, diverse set of data sources:
- Kaiser Permanente, Northern California (KPNC) (N=259).1
- University of California, San Francisco (UCSF) (N=395).2
- Center for Prostate Disease Research (CPDR) (N=402).3
A meta-analysis combining the UCSF and CPDR cohorts (N=732)20 provided more precise estimates for likelihood of adverse pathology.
20-Year outcomes21-22
A study suggests that the Oncotype DX GPS assay may be prognostic for both distant metastasis and prostate cancer-specific mortality through 20 years after diagnosis, and that the GPS assay together with clinical factors may improve risk assessment over clinical factors alone.
21
In a large cohort of men with largely clinically low risk prostate cancer treated with radical prostatectomy, the study suggests the presence of adverse surgical pathology significantly predicted 20-year risk of metastasis and prostate cancer specific mortality. Patients with adverse pathology at radical prostatectomy had a twelve-fold higher risk of metastasis than those with favorable pathology, demonstrating the value of this endpoint for assessing risk in this population.
22