FDA Finalizes Next Generation Sequencing Genetic Tests to Accelerate Reliable Development
FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
The U.S. Food and Drug Administration on April 12th 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.
