NGS Guidances Set the Stage for Precision Medicine Initiative

The FDA is creating a new flexible regulatory pathway for genomic tests that sequence the human genome as part of President Obama’s Precision Medicine Initiative.

The agency released two complementary draft guidances that set a foundation for the pathway by streamlining submission and review of data supporting clinical validity of next-generation sequencing-based in vitro diagnostics.

The agency sought feedback from industry stakeholders during four public meetings before crafting the guidances, which explain how the agency might consider exempting certain NGS-based tests from premarket review, Assistant Commissioner Heidi Marchand said.

The move represents FDA’s commitment to harness technology and share genomic findings pouring out of clinical research, she said. — Tamra Sami