Pathologists Argue LDT Rule Could Limit Access To Accurate Hospital Lab Tests

By Maaisha Osman / February 28, 2024 at 10:46 AM

The College of American Pathologists (CAP) is raising concerns that the proposed rule designating laboratory-developed tests (LDTs) as medical devices might significantly reduce the availability of accurate LDTs in hospital labs, but FDA Commissioner Robert Califf says the agency’s oversight on LDTs would improve accuracy of test results.


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