The Oncotype DX Genomic Prostate Score (GPS) test was developed to help men newly diagnosed with early-stage prostate cancer to make the most informed treatment decision for their individual disease, including active surveillance. The vast majority of men currently diagnosed with low-risk prostate cancer undergo surgery or radiation treatment, although there is only a three percent chance that their disease will become life-threatening. In response to this issue, Genomic Health’s tissue biopsy-based, multi-gene test has been clinically validated to predict aggressive cancer at the time of diagnosis, helping to identify those men who need immediate surgery or radiation therapy versus those who can confidently choose active surveillance. Using minimal tumor tissue from the original needle biopsy, the test builds on traditional clinical and pathologic factors to provide additional, clinically relevant insight into the underlying tumor biology of an individual patient before the prostate is removed. The result is a more precise and accurate assessment of risk, which helps more men avoid the lifelong complications associated with treatments they do not need, while directing aggressive therapy to those men who require immediate treatment.
With 18 publications featuring the Genomic Prostate Score test, including more than 4,500 patients, we have developed, validated, and continued to study the only genomic test to assess the aggressiveness of prostate cancer and predict both near- and long-term outcomes to enable more precise patient risk stratification and better informed treatment decisions, giving physicians the confidence to place many low- to intermediate-risk patients on active surveillance.
The Oncotype DX prostate cancer test is now covered for qualified patients by Medicare in the United States, giving nearly 60,000 prostate cancer patients the opportunity to personalize their cancer treatment.
The Oncotype DX AR-V7 Nucleus Detect test is designed to guide treatment decisions for men with metastatic castration-resistant prostate cancer (mCRPC), an advanced stage of the disease in which the cancer continues to grow and spread despite androgen deprivation therapy (ADT). mCRPC is often treated with androgen receptor-signaling inhibitor (ARSI) therapies – such as Zytiga® (abiraterone) or Xtandi® (enzalutamide). However, one in three patients become resistant to ARSI therapy after two rounds of treatment, leading to poor outcomes and unnecessary treatment costs.
The clinically and analytically validated blood-based Oncotype DX AR-V7 Nucleus Detect test identifies late-stage prostate cancer patients who are positive for the AR-V7 protein, a predictive and prognostic biomarker that signals that a patient has become resistant to ARSI therapy. If the test detects AR-V7-positive tumor cells circulating in the blood of a patient with advanced prostate cancer, it means the patient has built resistance to the commonly prescribed ARSI therapies and should either switch to chemotherapy or start another type of therapy, which has been shown to prolong survival.
To bring the Oncotype DX AR-V7 Nucleus Detect test to market, Genomic Health, Inc. and Epic Sciences, Inc. entered into an exclusive agreement under which Genomic Health commercializes Epic Sciences’ novel AR-V7 liquid biopsy test in the United States through Genomic Health’s world-class oncology and urology sales and medical liaison teams. The Oncotype DX AR-V7 Nucleus Detect test will be performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego. Powered by Epic Sciences’ No Cell Left Behind® technology, the test analyzes each nucleated cell in the blood sample, an unbiased approach to ensure that no circulating tumor cells (CTCs) are left behind, resulting in superior test performance, sensitivity and specificity.
The Oncotype DX AR-V7 Nucleus Detect test is the first and only liquid biopsy test of its kind that can help doctors prolong the lives of the 50,000 men diagnosed with mCRPC in the United States each year.