AR-V7 Liquid Biopsy Test
Our new AR-V7 test has a revolutionary component: Confidence.
Virtually all men with metastatic prostate cancer will eventually develop mCRPC, an advanced stage of the disease. To spare patients and physicians the anxiety around choosing a correct therapy we’d like to suggest a novel test, requiring only a simple blood draw, that will allow them to proceed with confidence: Epic Sciences’ AR-V7 CTC liquid biopsy test — a test so sensitive and so precise that doctors can predict with confidence which therapies will be beneficial and which will not.
The world’s first predictive test for prostate cancer.
Our AR-V7 test for prostate cancer was the result of a radically different approach to cancer research. Rather than developing a technology and trying to find out where it might be useful in the field, we started with the clinical question. This has allowed us to tailor our technology — whether it’s higher resolution images, different stains and antibodies, or different morphological features — to answer that clinical question, and in turn drive our development program. It’s a bias-free approach — a unique rare cell detection engine that looks at all the cells in a blood sample and sees the cancer cells that others miss.
Epic’s technology can thus see, identify and characterize all the circulating tumor cells (CTCs) in a blood sample, and link their response or resistance to a panoply of drug classes. Specifically, the Epic AR-V7 test identifies patients who are likely to be resistant to androgen-directed therapies such as Zytiga® or Xtandi®. Thus alerted, a physician might instead choose to triage the patient with a taxane chemotherapy, which has been statistically shown to increase a patient’s overall chances of survival (JAMA Oncology, 2016).
Few things are certain in life, but the knowledge that you’ve made an informed choice and perhaps helped someone live a longer, healthier life is welcome news at any time.
How does the test work?
Now available, the AR-V7 test is laboratory-developed and validated, and will be performed exclusively by Epic Sciences. It has not been cleared or approved by the US Food and Drug Administration. Although laboratory-developed tests, to date, have not been subject to US FDA regulation, certification of the laboratory is required under Clinical Laboratory Improvement Amendments (CLIA) to ensure the quality and validity of the tests. Epic Sciences is certified under US CLIA as qualified to perform high-complexity clinical laboratory testing, and is accredited by the College of American Pathologists (CAP).
Available exclusively through Genomic Health in the U.S.
Genomic Health has the exclusive distribution rights to market and sell the new Epic Sciences AR-V7 liquid biopsy test in the U.S. The test is offered through Genomic Health where physicians can order the test and view the results through Genomic's physician portal.
All tests are performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego, California.
Learn more about the AR-V7 test.
AR-V7 Patient Story: ABC 10 San Diego
Bryce Olson discusses the Oncotype DX® AR-V7 Nucleus Detect™ test, developed by Epic Sciences and commercially available through Genomic Health, with ABC 10 News. The test determines which men with late-stage metastatic prostate cancer will benefit from AR-targeted therapy or chemotherapy.
Medicare Establishes Final Local Coverage Determination (LCD) for Use of the Oncotype DX® AR-V7 Nucleus Detect™ Test in Patients with Metastatic Castrate Resistant Prostate Cancer, Effective December 10, 2018. Press Release.
To request a copy of the original investigation as published in JAMA Oncology, 2016, or to learn more about the Oncotype DX AR-V7 Nucleus Detect Test and how to order, please provide your contact information and an Epic team member will contact you shortly.