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?
|
Key Dates
-
June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC