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FDA Pathway Options Are Growing For Diagnostics, FDA's Gottlieb Tells Commercial Labs

 
• By Sue Darcey

While lab-developed test (LDTs) remain under a US FDA enforcement discretion policy, the agency is working on several fronts to offer appealing regulatory pathways for advanced diagnostic services, FDA Commissioner Scott Gottlieb told American Clinical Laboratory Association members.

FDA commissioner Scott Gottlieb
Scott Gottlieb

Legislative changes to US FDA's laboratory-developed test (LDT) regulations, proposed pre-certification pilots, and letting well-qualified third-party reviewers like New York State's Department of Health review new LDTs are all ways clinical labs could get their tests to market quickly, agency chief Scott Gottlieb emphasized to commercial lab leaders last week.

Speaking at an American Clinical Laboratory Association meeting in Washington, DC, Gottlieb detailed recent innovations made in DNA-based testing, as

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