As the new Congress and a new administration start up, the fate of FDA-issued regulations on laboratory-developed tests (LDTs) is one of many issues that health advocates and lobbyists will be ...

An evaluation uncovers more variability than expected in basic blood tests of healthy adults. The study focused on common blood tests, which typically return a single data point or a few data points.

The U.S. trade group representing laboratory companies and test manufacturers is suing to block the FDA from increasing its oversight of lab-developed tests, saying the agency overstepped its ...