AMA: FDA Should Have Authority Over 'Black-Box' Tests, But Not All LDTs

American Medical Association this week weighed in on how it would like to see House lawmakers tackle laboratory-developed tests in their evolving 21st Century Cures bill: The physicians group says only a small subset of complex genetic and genomic tests should be subject to FDA regulation and otherwise opposes the LDT framework developed by the agency last year. The group urges lawmakers to only give FDA authority over tests for which incorrect results could harm patients and for which test...