CARLSBAD, Calif., March 19, 2018 /PRNewswire/ -- Thermo Fisher Scientific today announced its Oncomine Dx Target Test has been approved for coverage by the Centers for Medicare & Medicaid Services (CMS) as part of the agency's national coverage determination (NCD) for next-generation sequencing (NGS) in vitro diagnostic (IVD) tests. Combined with positive reimbursement decisions from commercial health insurers, Oncomine Dx Target Test is now available to more than 160 million lives in the United States.
The progress comes as payors move to broaden access to data rich, multigene panel testing, which can help oncologists and pathologists more quickly identify targeted therapies or appropriate clinical trials for their patients. The agency's NCD - NGS for Medicare Beneficiaries with Advanced Cancer (CAG-00450N) - now puts in place a reimbursement path for cancer patients who are tested with Thermo Fisher's multi-biomarker diagnostic for non-small cell lung cancer (NSCLC), which is the first test of its kind to receive approval by the U.S. Food and Drug Administration (FDA).
"The extension of coverage to 50 percent of the U.S. population underscores the significant traction NGS-based tests are gaining to more effectively select targeted therapies in this age of precision medicine," said Joydeep Goswami, President of Clinical Next-Generation Sequencing and Oncology, at Thermo Fisher Scientific. "As more health plans recognize their value, further adoption of these companion diagnostics will follow – enabling patients to benefit from improved health outcomes and better efficiencies in the cost of their treatments."
Oncomine Dx Target Test, which simultaneously evaluates 23 genes clinically associated with NSCLC, enables physicians to match patients to FDA-approved therapies in just days instead of several weeks, which it often takes when screening patient samples one biomarker at a time.
Oncomine Dx Target Test received FDA approval in June 2017, followed by a number of positive reimbursement decisions soon after by many of the country's largest health insurers, including: CIGNA, Aetna, UnitedHealthcare, Independence Blue Cross and Humana. The test has also been adopted by several national reference laboratories, including Quest Diagnostics, Cancer Genetics, Inc., NeoGenomics Laboratories and LabCorp's Diagnostics and Covance businesses.
Lung cancer is the leading cause of cancer-related deaths in the U.S., with NSCLC accounting for 85 percent of all lung cancers.1 According to the American Cancer Society, each year more people die of lung cancer than of colon, breast and prostate cancers combined. It also estimates that there will be more than 1.7 million new cases of cancer in 2018, 14 percent of which will be lung cancers.
More information about the Oncomine Dx Target Test is available at www.thermofisher.com/oncomine-dxtarget.
1. Non–Small Cell Lung Cancer: Epidemiology, Risk Factors, Treatment, and Survivorship; Julian R. Molina, MD, PhD, Ping Yang, MD, PhD, Stephen D. Cassivi, MD, Steven E. Schild, MD, and Alex A. Adjei, MD, PhD
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $20 billion and approximately 70,000 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 www.thermofisher.com.
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