TL45: Next Generation Sequencing Diagnostic Tests
Meijuan Li, US Food and Drug Administration  *Peggy Wong, Merck 

Keywords: Next Generation Sequencing, Diagnostic tests, FDA Regulatory Oversight

On February 20, 2015, the FDA held a Public Workshop on Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests. The purpose of this roundtable is to exchange of ideas on 1) different types of challenges when working with the next generation sequencing (NGS) (assay analytical and clinical validation, operational challenges) and 2) opportunities involving NGS, especially as a diagnostic. Are there any lessons learned either in a discovery or validation stage? What challenges are other statisticians facing as non-statisticians explore the NGS data? Is there any practical considerations in using the specialized packages or the use of the cloud to store NGS data? How can the NGS data be shared in a precompetitive manner?