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Toward Better Oversight of NGS Tests.

Cancer discovery - 1 Sept 2016

Abstract excerpt

The FDA has published two draft guidance documents aimed at streamlining its oversight of tests based on next-generation sequencing (NGS). One contains preliminary recommendations addressing the analytic validity of NGS-based tests for hereditary diseases; the other explains how test developers can obtain official recognition of their genetic variant databases, potentially speeding marketing clearance or approval.

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Methodology Data sources Editorial policy Privacy Delete account & data About Contact Helena Bioinformatics

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PMID: 27457361
DOI: 10.1158/2159-8290.CD-NB2016-096

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