Press Announcements > FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests

Press Announcements > FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests





FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests

The agency is leveraging new tools and policies to advance the creation of innovative genetic and genomic-based tests and help ensure the validity of their results

The U.S. Food and Drug Administration today finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments. The guidances provide recommendations for designing, developing, and validating tests that use the technology, called next generation sequencing (NGS), and will play an important role in the continued advancement of individualized, genetic-based medicine. Continue reading.