Epic Sciences and Genomic Health Announce Favorable Draft Local Coverage Determination (LCD) on Medicare Coverage for Use of the Oncotype DX® AR-V7 Nucleus Detect™ Test in Patients with Metastatic Castration-Resistant Prostate Cancer
30 March 2018
Medicare Draft Coverage Supports Clinical Utility of the Oncotype DX AR-V7 Nucleus Detect Test, Providing 25,000 Medicare Patients with Coverage Once LCD Is Finalized
Epic Sciences, Inc. (Epic) and Genomic Health, Inc. (Nasdaq: GHDX) announced today that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a draft local coverage determination (LCD) for the Oncotype DX® AR-V7 Nucleus Detect™ test. The draft LCD recommends Medicare coverage for use of the test throughout the United States to help determine which patients with metastatic castration-resistant prostate cancer (mCRPC) 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 predictive and prognostic test in prostate cancer that can identify which patients will no longer benefit from ARSi therapies, such as enzalutamide and abiraterone, and need to switch to chemotherapy or start another type of therapy in order to extend life," said Murali Prahalad, Ph.D., president and CEO of Epic Sciences. "The rapid issuance of the draft LCD recommending Medicare coverage highlights the clinical utility and value of this new test in prolonging survival for men with metastatic castration-resistant prostate cancer."
Prior to the Oncotype DX AR-V7 Nucleus Detect test, there was no clear consensus on therapeutic sequencing after initial exposure to an ARSi therapy, and the most common clinical decision in mCRPC was whether to start a second ARSi or taxane chemotherapy. Detection of AR-V7-positive tumor cells indicates that the patient will no longer benefit from commonly prescribed ARSi therapies but can still benefit from chemotherapy, which has been shown to prolong survival. An estimated 50,000 men in the United States with advanced prostate cancer could benefit from knowing their AR-V7 status prior to selecting further treatment.
Epic's proprietary No Cell Left Behind® technology is delivering a portfolio of blood-based tests predictive of drug response in cancer that are clinically proven, personalized, and focused on improving healthcare economics worldwide.
The draft LCD, posted on the Medicare Coverage Database on the Centers for Medicare and Medicaid Services (CMS) website, will go through Medicare's review process, including a public comment period that started on March 26, followed by finalization and notification. LCDs are subject to annual review by MACs.
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 DetectTM 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, on Twitter @EpicSciences or on Facebook.com/EpicSciences.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that help optimize cancer care, including addressing the overtreatment of the disease, one of the greatest issues in healthcare today. With its Oncotype IQ® Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX ® gene expression tests that have been used to guide treatment decisions for more than 850,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype DX® AR-V7 Nucleus Detect™ test. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the benefits of the Oncotype Dx AR-V7 Nucleus Detect test to physicians, patients and payors. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the finalization of a local coverage determination for the test; the ability of the test to obtain Medicare reimbursement coverage throughout the United States; the risk that the company may not obtain or maintain sufficient levels of reimbursement; the results of clinical studies; the applicability of clinical study results to actual outcomes; the ability of the test results to change treatment decisions and improve patient outcomes; the risks and uncertainties associated with the regulation of the company's tests; the risks of competition; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's annual report filed on Form 10-K for the year ended December 31, 2017. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype Dx, and Oncotype Dx AR-V7 Nucleus Detect are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.