Ahead of a two-day public workshop on regulating next-generation sequencing tests, the US Food and Drug Administration has published discussion papers outlining the approaches it is considering and has asked stakeholders for feedback on specific questions.
 

Earlier this year, the agency held a workshop to discuss its plan to develop analytical standards for ensuring NGS test results are accurate and reliable, and to use curated variant databases to establish the clinical interpretation of such tests. Based on the public feedback, the FDA has refined its regulatory considerations and is asking for more specific guidance from the community.
 

On Nov. 12, the FDA workshop will focus on developing analytical standards for NGS testing, and on Nov. 13 the agency will discuss variant databases for clinical interpretation. Stakeholders can provide input at these workshops or in writing.