FDA Releases Draft Guidance on Regulating Next-Generation Sequencing-Based Diagnostics for Germline Diseases

Summary

The Food and Drug Administration (FDA) has released a draft guidance document outlining its proposed approach to regulating next-generation sequencing-based in vitro diagnostics for diagnosing germline diseases. The guidance aims to provide standards for designing, developing, and validating these tests, which are part of the White House's Precision Medicine Initiative.