Will Medicare Genetic Test Coverage Get Labs to Seek FDA Signoff?

Medicare’s decision to cover a limited number of personalized medicine tests for cancer patients could nudge laboratory testing companies to ask the FDA to approve them—something the FDA sought for several years.

An announcement by Medicare to cover genetic tests using next-generation sequencing (NGS) technology—only if they are FDA-approved companion diagnostics—could spur laboratory diagnostic testing companies to obtain the FDA’s blessing.

Clinical labs, already regulated by the Centers for Medicare and Medicaid Services (CMS), would prefer to avoid FDA oversight on top of that—what they’ve said would be double regulation. But the promise of Medicare coverage for NGS tests might ...