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Policy Category: Next-Generation Sequencing

PMC advises regulatory and reimbursement officials on the scientific principles underpinning next-generation sequencing (NGS)-based tests, which are capable of examining millions of DNA variants at a time. Between 2018 and 2019, PMC comment letters helped prompt the Centers for Medicare and Medicaid Services (CMS) to reconsider its policies related to coverage of NGS-based testing for Medicare patients with advanced cancers.

CMS’ Coverage of Next-Generation Sequencing-Based Diagnostic Tests

FDA’s Oversight of Next-Generation Sequencing-Based In Vitro Diagnostics

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