By Kelly A. Briganti, Editorial Director, G2 Intelligence
Building on discussions started in February this year, the FDA has announced two workshops it will be holding this fall regarding next-generation sequencing standards and use of databases to establish clinical relevance of genetic variants. The first workshop, to be held Nov. 12, will focus on potential analytical standards for next generation sequencing (NGS)-based in vitro diagnostic tests, including laboratory developed tests. The FDA seeks “sufficiently flexible assay performance standards that can accommodate innovation, including test modifications, while assuring NGS test safety and effectiveness.” The workshop will focus on regulatory strategies for assessing analytical validity of NGS tests that yield information about variations in the human genome. The FDA promises a white paper in advance of the workshop that will cover its “current thinking for a standards-based approach to analytical performance evaluation of NGS diagnostic tests.”
A second workshop will be held the next day, Nov. 13, addressing use of curated databases in regulation of NGS tests, which have often been promoted as a means to establish clinical relevance of genetic testing. That workshop will focus on development, operation and curation, and use of databases of genetic variants. A discussion paper to be released prior to the workshop will address possible uses for such databases and the issues to be addressed at the workshop.
Earlier this year, a February workshop, titled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests,” focused on the issues raised by the unique nature of NGS and difficulties concerning demonstration of analytical and clinical performance—including the need for standards and the potential for use of curated databases. These latest two workshops continue those discussions.
For both workshops, attendees must register for in person or webcast attendance by Oct. 30, requests to make public comment must be made by Oct. 26, and written comments on the issues can be submitted until Nov. 25, 2015. Registration, agendas and other information for both workshops can be found on the FDA’s website.