Stakeholders: Keep Communication About NGS Tests Outside FDA Purview

Stakeholders told FDA during a public workshop Friday (Feb. 20) on the agency's potential new approach to next-generation sequencing tests that communication regarding certain information from such tests should continue to be considered practice of medicine and fall outside of FDA regulation. The meeting also touched on the challenges of getting payer coverage for such tests. FDA held the meeting to gather feedback on its plan to regulate NGS tests differently from other laboratory-developed tests, which the agency is moving...