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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » For Lab Industry, FDA Draft Guidance on NGS Testing Inseparable From Larger LDT Debate

For Lab Industry, FDA Draft Guidance on NGS Testing Inseparable From Larger LDT Debate

Jul 11, 2016
|
Turna Ray
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NEW YORK (GenomeWeb) – After releasing white papers, holding several public workshops, and listening to stakeholder feedback, the US Food and Drug Administration has released two draft guidances outlining how it might review the analytical and clinical validity of next-generation sequencing tests.

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