title: Toward Better Oversight of NGS Tests.
abstract: The FDA has published two draft guidance documents aimed at streamlining its oversight of tests based on next-generation sequencing (NGS).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.
mesh_terms: D014644:Genetic Variation; D017408:Guidelines as Topic; D059014:High-Throughput Nucleotide Sequencing / Q000592:standards*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D012107:Research Design / Q000592:standards; D017422:Sequence Analysis, DNA / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration