Trade groups and others responding to FDA draft guidance documents on next-generation sequencing (NGS) for diagnosing germline (inheritable) diseases praised the concepts, but questioned some of the specifics of the agency’s plans.
The first guidance document discusses how companies can design, develop and validate their tests that can identify millions of genetic variants relying in part on FDA-recognized standards, while...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?