VALID Act cues up diagnostics regulation revamp

U.S. legislators got one step closer to erasing the controversial distinction between diagnostic tests distributed as kits versus those run in centralized labs via Thursday’s reintroduction of the VALID Act. Despite bipartisan and bicameral support, it will likely have to wait until the next PDUFA reauthorization in 2022 to become law.

The Verifying Accurate, Leading-edge IVCT Development (VALID) Act would create a single regulatory framework covering both in vitro diagnostics (IVDs) -- which are sold as kits that can be processed by any provider and are subject to premarket FDA review -- and laboratory-developed tests (LDTs) -- which are only processed by the labs that originated the technology and do not require FDA approval. ...