Epic Sciences Inc, San Diego, has announced 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.
The Oncotype DX AR-V7 nucleus detect test is a circulating tumor cell-based liquid biopsy that helps clinicians to determine which patients may benefit from androgen receptor signaling inhibitor therapy and which may benefit from chemotherapy. The test is now 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,” says Pascal Bamford, PhD, chief scientific officer and head of laboratory operations at Epic Sciences. “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.”
To obtain licensure to serve the approximately 5,000 men in New York with advanced prostate cancer, Epic Sciences submitted 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.
Last October, Palmetto GBA issued a positive final local coverage determination for the Oncotype DX AR-V7 nucleus detect test, which became effective December 10, 2018. The test is now covered by Medicare in the United States for qualified patients, giving them the opportunity to personalize their cancer treatment.
For further information, visit Epic Sciences.