Patient Groups Split On FDA's Laboratory-Developed Test Proposal

Lung cancer and Lyme disease patient advocates are pushing for FDA to rescind its proposed framework for laboratory-developed tests (LDTs) and leave regulatory oversight to CMS, citing concerns that the agency's plan will limit patient access to necessary tests, while other healthcare stakeholders instead are embracing FDA oversight while calling for some changes in the agency's approach. One group said it appreciated FDA's risk-based approach, but did not think the medical device classification system was appropriate for LDTs. FDA laid...