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The first FDA marketing authorizations of next-generation sequencing technology and tests: challenges, solutions and

Karen Bijwaard1, Jennifer S Dickey, Kellie Kelm

  • 1Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH, US FDA, 10903 New Hampshire Ave, Silver Spring, 20993, USA.

Expert Review of Molecular Diagnostics
|November 6, 2014
PubMed

Keywords:
assaycystic fibrosisdiagnostichigh throughput sequencinginstrumentmedical devicenext generation sequencingregulationsequencing by synthesis

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