CMS Issues Proposed National Coverage Determination of NGS IVDs Including Thermo Fisher Scientific's Oncomine Dx Target Test

CARLSBAD, Calif., Dec. 7, 2017 /PRNewswire/ -- The Centers for Medicare & Medicaid Services (CMS) has proposed coverage for the Oncomine Dx Target Test as part of a national coverage determination (NCD) for next-generation sequencing (NGS) in vitro diagnostic (IVD) tests. Once implemented, the NCD would provide Medicare beneficiaries with reimbursable testing using Thermo Fisher Scientific's multi-biomarker non-small cell lung cancer (NSCLC) diagnostic.

Oncomine Dx Target Test is designed to identify patients who may be eligible for treatment with one of three U.S. Food and Drug Administration (FDA)-approved targeted therapies for NSCLC. The proposed coverage determination also extends to clinical trials that meet a specific set of criteria, including the NCI-MATCH trial, which uses a standardized NGS protocol developed with Thermo Fisher's Oncomine reagents and Ion Torrent sequencing systems.

"NGS unlocks new opportunities in genomic-based medicine helping oncologists match patients to available therapies," said Joydeep Goswami, president of clinical next-generation sequencing and oncology for Thermo Fisher Scientific. "While the clinical research community has embraced the technology for some time now, it's encouraging to see CMS recognize the value of NGS testing both from a patient and drug development perspective."

The Oncomine Dx Target Test was the first companion diagnostic test approved by the FDA to simultaneously screen for multiple NSCLC therapies, enabling physicians to match patients to FDA-approved therapies in days instead of several weeks. Since gaining FDA approval in June 2017, the Oncomine Dx Target Test received its first positive coverage decision for regional coverage in Oregon, Idaho, Utah and select counties of Washington.

"As leaders in targeted sequencing, our Oncomine and Ion Torrent technologies continue to play integral roles in advancing precision medicine, from helping to drive ground-breaking clinical trial designs through our multi-gene panels, to enabling development of new cancer therapies," said Goswami. "We applaud the steps the FDA and CMS continue to take in realizing the impact precision medicine can have on improving health outcomes and encourage the clinical community to voice their support of this decision during the public comment period."

The draft NCD would cover Medicare beneficiaries with advanced cancer (i.e., recurrent, metastatic or advanced stage IV cancer), who have not been previously tested using the same NGS technology. The final policy is expected to be issued during the first quarter of 2018 following public comment of the preliminary NCD.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit

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SOURCE Thermo Fisher Scientific Inc.