A US District Court judge on March 31 nullified the Food and Drug Administration (FDA) regulation on the oversight of laboratory-developed tests (LDTs), agreeing with plaintiffs’ and the College of American Pathologists’ (CAP) arguments that the rule should be vacated.
Laboratory-Developed Test Oversight
The CAP advocates for strengthened oversight of laboratory-developed tests to protect patients by ensuring every laboratory-developed test is reported to an oversight body.