For years the FDA have been concerned with the safety risks of poorly performing Laboratory Developed Tests (LDTs). Despite multiple attempts to regulate the space including the ‘FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)’ in 2014 and the recent ‘Verifying Accurate Leading-edge IVCT Development Act’ (VALID Act) from 2022, the concerns have not provided the desired outcome.
In November 2022 FDA oncology chief Richard Pazdur announced that the agency’s medical device regulators were working on a pilot program to introduce a concept of minimum performance criteria with the objective to move past the ‘one-drug-one-test’ situation.
The new initiative and pilot program was intended to allow doctors to use any test that meets a set of minimum criteria, regardless of if specifically approved for therapy. The objective announced was to avoid patients undergoing multiple tests and using unnecessary amounts of valuable tissue which is increasingly becoming a limiting factor in timely and efficient diagnostic work up.
The FDA also hopes the new initiative will lead to the laboratory community delivering more reliable tests and finally finding a path to better management of LDT performance.