Clinical OMICS

JAN-FEB 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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www.clinicalomics.com January/February 2018 Clinical OMICs 19 In December, Thermo Fisher Scientific received a coverage proposal from the Centers for Medicare & Medicaid Services (CMS) for its Oncomine Dx Target Test, a multi-biomarker non-small cell lung cancer (NSCLC) diagnostic, as part of a national coverage determination (NCD). The NCD covers next-generation sequencing (NGS) in vitro diagnostic (IVD) tests that include Oncomine Dx Tar- get Test. The multi-biomarker NSCLC diagnostic is designed to identify patients who may be eligible for treatment with one of three FDA-approved targeted therapies for the disease. Oncomine Dx Target Test is designed to detect 368 vari- ants in 23 cancer-associated genes clinically associated with NSCLC—three biomarkers validated for selection of rel- evant targeted therapies (EGFR, ROS1, or BRAF), and 20 additional genes, relevant for NSCLC pathogenesis analyti- cally validated for variant detection from NSCLC tissue. "The proposed NCD could apply to additional indica- tions as Thermo Fisher continues to work with pharmaceu- tical partners to expand the Oncomine Dx Target Test with additional CDx markers in NSCLC, and into new indica- tions beyond NSCLC," said Robert Dumanois, manager, reimbursement strategy for clinical sequencing product management at Thermo Fisher Scientific. "Thermo Fisher is currently in negotiations with pharma companies that are interested in adopting the Oncomine Dx Target Test as a CDx for drugs in their current pipeline." The company also has ongoing CDx collaboration with Agios Pharmaceuticals and Blueprint Medicines. The proposed coverage determination extends as well to clinical trials that meet a specific set of criteria—including the NCI-MATCH trial, which uses a standardized NGS pro- tocol developed with Thermo Fisher 's Oncomine reagents and Ion Torrent sequencing systems. CMS is expected to issue a final policy during the first quarter of 2018 following public comment of the preliminary NCD. "Payer coverage is essential to market success. NSCLC demographics are important," Dumanois said. "A CMS decision weighs heavily on coverage for the majority of U.S. patients. Many commercial payers also look to CMS coverage and payment policies to inform their own plan's guidelines." He cited statistics from the American Cancer Society not- ing that two-thirds of NSCLC patients are over age 65, and that the average age at diagnosis is 70. Oncomine Dx Target Test uses a single sample to deliver multiple biomarker results, vitally important for the diag- nosis of some cancer where tissue biopsies may be limited. Results from the test are presented in a single, two-part report that incorporates NSCLC biomarker results, associ- ated therapy indication(s), and other biomarker results. According to Thermo Fisher, workflow turn-around time is four days from sample extraction to clinical test report. The Oncomine Dx Target Test was approved by the FDA in June as the first authorized companion diagnostic test to screen for multiple NSCLC therapies simultaneously, cut- ting from several weeks to just days the time physicians needed to match patients to FDA-approved treatments. Oncomine Dx Target Test is already available nationally and can be ordered by physicians through Thermo Fish- er 's partner labs, including Cancer Genetics, LabCorp, and NeoGenomics. In October, the test received a positive coverage decision by Regence BlueCross/BlueShield, making it available to plan beneficiaries in Oregon, Idaho, and Utah, and in select counties of Washington. —Alex Philippidis CMS Proposes Coverage for Thermo Fisher Scientific NSCLC Diagnostic Thermo Fisher Scientific's Ion PGM Dx system is designed for regulated laboratory environments.

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