Strategic Collaboration to Deliver Novel AR-V7 Liquid Biopsy Test to Predict Treatment Response in Metastatic Prostate Cancer (mCRPC) announced by Genomic Health and Epic Sciences

Validation Study Led by Memorial Sloan Kettering Cancer Center, Published in JAMA Oncology, Demonstrated Patients with AR-V7 Positive Circulating Tumor Cells Have Significantly Better Outcomes if Treated with Chemotherapy versus Hormonal Treatments - 

REDWOOD CITY, CA and SAN DIEGO, CA. Genomic Health, Inc. and Epic Sciences, Inc. announced an exclusive agreement to commercialize Epic Sciences' novel AR-V7 liquid biopsy test in the United States through Genomic Health's  commercial channel. The blood-based test detects the V7 variant of the androgen receptor protein (AR-V7) in the nucleus of circulating tumor cells (CTC) - information that can help guide treatment selection in patients with metastatic castration-resistant prostate cancer (mCRPC).

AR-V7 expression has been associated with resistance to hormone therapy drugs called androgen receptor signaling (ARS) inhibitors. A recently published study in JAMA Oncology from Memorial Sloan Kettering Cancer Center demonstrated that mCRPC patients with AR-V7 positive CTCs had significantly better clinical outcomes when treated with taxane chemotherapy, which suggests that patients with detectable blood levels of AR-V7 should consider life prolonging chemotherapy. These study results underscore the potential for an AR-V7 predictive test to allow advanced prostate cancer patients to avoid ineffective therapies and to receive chemotherapy at an earlier stage when it may be more beneficial.
"The validation study published in JAMA Oncology demonstrated that patients with AR-V7 positive CTCs have longer survival on taxane chemotherapy relative to those on AR signaling inhibitors," said Dr. Howard Scher, M.D., study principal investigator and chief of Genitourinary Service at Memorial Sloan Kettering Cancer Center, New York. "The growing body of evidence for the clinical utility of AR-V7 supports its use in clinical practice as a treatment-specific biomarker to guide treatment selection for patients with advanced prostate cancer."
Virtually all men with metastatic prostate cancer eventually develop mCRPC, an advanced stage of the disease where the standard of care includes abiraterone, enzalutamide and taxanes. It is estimated that each year, about 50,000 mCRPC patients could benefit from knowing their AR-V7 status prior to selecting further treatment. With the use of this new test, the two companies estimate substantial healthcare savings per patient tested by tailoring treatment selection. "Epic Sciences' no cell left behind® platform offers the highest clinical sensitivity and specificity for nuclear AR-V7 characterization. This enables a best-in-class test that provides clinically actionable information that can directly affect patient outcomes and health economics," said Murali Prahalad, president and chief executive officer, Epic Sciences. "The Epic Sciences AR-V7 test is the first of many groundbreaking tests we are developing, and our collaboration with Genomic Health is an important milestone to realize its commercial potential with a world-class partner."   

"This strategic collaboration allows us to leverage our successful commercial channel while continuing to generate growth across our business," said Frederic Pla, Ph.D., chief business and product development officer, Genomic Health. "Epic Sciences' industry leading CTC-based platform enables the delivery of clinically actionable information to prostate cancer patients at a critical treatment decision point. Offered as part of our Oncotype IQ™ Genomic Intelligence Platform that collectively assesses DNA, RNA, and protein using either PCR, NGS, or image-based analysis, Epic Sciences' AR-V7 test will complement our expanding portfolio, which also includes Oncotype SEQ™, our recently launched liquid biopsy mutation panel."

Based on the agreement, Genomic Health will have exclusive distribution rights to market and sell the new Epic Sciences liquid biopsy test in the U.S. beginning in early 2017. The test will be offered through Genomic Health's commercial channel to enable physicians to order the test and view the results through the current physician portal. The test will be performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego, California.

1. Scher HI, Lu D, Schreiber NA, et al. Association of AR-V7 on Circulating Tumor Cells as a Treatment-Specific Biomarker With Outcomes and Survival in Castration-Resistant Prostate Cancer. JAMA Oncol. Published online June 04, 2016. doi:10.1001/jamaoncol.2016.1828.

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