SAN DIEGO, Calif., March 20, 2019 -- Epic Sciences, Inc. (Epic) announced today that the New York State Department of Health has completed licensure to provide the Oncotype DX AR-V7 Nucleus Detect™ test for patients with metastatic castration-resistant prostate cancer (mCRPC). The Oncotype DX AR-V7 Nucleus Detect test helps determine which patients may benefit from androgen receptor signaling inhibitor (ARSi) therapy and which may benefit from chemotherapy. The Oncotype DX AR-V7 Nucleus Detect test is a circulating tumor cell (CTC)-based, liquid biopsy test that is commercially available in the United States through Epic's partnership with Genomic Health.
“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 men diagnosed with metastatic castration-resistant prostate cancer. We achieved this important regulatory milestone and met the state department of health’s very high standards by demonstrating the test’s excellent accuracy and ability to extend lives. Patients and physicians in New York can now access this powerful information to guide therapy decisions,” said Pascal Bamford, Ph.D., Chief Scientific Officer and Head of Laboratory Operations.
To obtain this licensure to serve the approximately 5,000 men in New York with advanced prostate cancer, Epic Sciences submitted to NYSDOH a robust dossier of data published in JAMA Oncology establishing the predictive benefit of the test, in addition to analytical performance data demonstrating the quality of the test.
In October, Palmetto GBA issued a positive final Local Coverage Determination to provide coverage for the Oncotype DX AR-V7 Nucleus Detect test, effective December 10, 2018. The test is now covered by Medicare in the U.S. for qualified patients, giving them the opportunity to personalize their cancer treatment.
About Epic Sciences
Epic Sciences, Inc. is developing novel diagnostics to personalize and advance the treatment and management of cancer. Epic Sciences' mission is to enable the rapid and non-invasive detection of genetic and molecular changes in cancer throughout a patient's journey. The company was founded on a powerful platform to identify and characterize rare cells, including circulating tumor cells. Epic Sciences No Cell Left Behind® technology helps match patients to therapies and monitor for drug resistance, so that the best treatment path can be chosen at every clinical decision point. Epic Sciences has partnered with Genomic Health to commercialize the Oncotype DX AR-V7 Nucleus Detect test, which helps with therapeutic decisions between taxane chemotherapy or androgen-directed therapeutics in metastatic castrate-resistant prostate cancer. Today, we partner with leading pharmaceutical companies and major cancer centers around the world. Epic Sciences' goal is to increase the success rate of cancer drugs in clinical trials and improve patient outcomes by providing physicians real-time information to guide treatment choices. Epic Sciences is headquartered in San Diego. Further information is available on the Company's website, www.epicsciences.com. Stay in touch on LinkedIn or on Twitter @EpicSciences.
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