FDA releases Next Gen Clinical Sequencing Guidance: For Infectious Disease

On May 13, 2016 FDA released a draft 46 page guidance on how device manufacturers in the next generation sequencing industry can approach approval for diagnostics related to infectious disease.

The guidance is online here.  Comments are accepted for 90 days (until about August 12, 2016).  The guidance follows a workshop on microbial sequencing held two years ago, on April 1, 2014, and also adapts information from an April 2015 colloquium held in conjunction with ASM.