A New York Minute: US FDA Leverages State's Health Department To Expedite NGS Reviews

The agency authorized a next-generation sequencing tumor profiling system that leverages the New York State Department of Health to speed future clearances.

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US FDA took an important step to advance policies for laboratory-developed tests services and next-generation sequencing with a Nov. 15 de novo classification of a tumor-profiling system.

The de novo in question was granted – with a class II, 510(k) risk designation – to MSK-IMPACT, a next-generation sequencing (NGS) system, developed as a clinical-grade test at Manhattan-based Memorial Sloan

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