FDA gets earful on LDTs

An overwhelming majority of attendees at a two-day workshop to discuss FDA's draft guidance on laboratory-developed diagnostic tests (LDTs) were opposed to the guidance, which seeks to outline a new regulatory path for approving such tests.

Over two-thirds of participants representing independent, academic and hospital labs as well physicians and pathologists felt that the agency's attempts to regulate LDTs would be redundant because the tests and laboratories performing the tests are subject to review by CLIA. Moreover, the stakeholders were concerned the guidance requirements that new tests or modifications of existing tests undergo FDA review would be too costly, which could put many small and regional laboratories out of business. ...