Tuesday, January 5, 2016

FDA Posts Transcripts of November 2016 Next Gen Sequencing Workshops

On November 12, 2015, the FDA held a workshop on analytical performance for next generation sequencing tests.  On the next day, November 13, the FDA followed with a workshop on the use of public databases as reference standards "the clinical relevance of genetic variants."  The FDA has now published transcripts of both conferences.   (Other materials, such as agendas, webcasts, and Powerpoints, are also online at the FDA.)

For the main documents web page on the November 12 meeting, NGS analytical standards, here.  For the 380-page transcript, here.

For the main documents web page for the November 13 meeting, variant databases, here.   For the 196-page transcript, here.