The Food and Drug Administration has released two draft guidance documents that seek to provide a streamlined oversight process for genomic tests as part of the Precision Medicine Initiative established by the Obama Administration.
FDA proposed a new regulatory system meant to help manufacturers accelerate the development of genetic screening devices, the White House said Wednesday.
The draft guides outline standards for next generation sequencing-based in vitro methods to diagnose germline diseases as well as the use of genetic databases to support clinical evaluation of NGS-based in vitro diagnostics.
The agency crafted the policies in an effort to help developers market genomic tests based on community standards and scientific evidence, according to the White House.
There will be a 90-day comment period on the guides.
PMI aims to foster biomedical discoveries to provide tailored prevention and treatment strategies for a patient’s unique characteristics.