Lab Industry Unprepared For FDA Action on LDTs

CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by the lab industry press is the simple fact that, if the FDA were to …

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Lab Industry Unprepared For FDA Action on LDTs

Laboratory-developed tests (LDTs) performed daily in almost every clinical laboratory in the U.S.

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