FDA Reopens Comment Period on Strategies for NGS Tests

The FDA is reopening the comment period for feedback on challenges and opportunities of regulating next-generation sequencing-based clinical tests, responding to requests from stakeholders who need additional time to submit input.

The comment period closed on Nov. 25, but it has been extended until Dec. 24, the FDA announced last week.

The FDA held two workshops on the topic on Nov. 12 and 13.

The first workshop focused on analytical performance evaluation standards that developers can use to ensure accuracy and reliability of tests results. The second explored how stakeholders can develop curated databases that correlate genetic changes with different conditions and diseases (IDDM, Sept. 11).

Read the Federal Register notices here: www.fdanews.com/12-15-FDA-NGS.pdf and www.fdanews.com/12-15-FDA-HGV.pdf. — Jonathon Shacat