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

US Food and Drug Administration – 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.

“As disease detection technologies rapidly evolve, so too must the FDA’s approach to reviewing these new innovations,” said FDA Commissioner Scott Gottlieb, M.D. “The new policies issued today provide a modern and flexible framework to generate data needed to support the FDA’s review of NGS-based tests, and give developers new tools to support the efficient development and validation of these technologies.”

NGS works by looking at a person’s DNA to detect genomic variations that may determine whether a person has or is at risk of developing a genetic disease and, in certain cases, may help to inform treatment decisions. Unlike traditional diagnostics that typically detect chemical changes associated with a single disease or condition, NGS can look at millions of DNA changes in a single test to help determine the cause of a person’s disease or condition. Availability of these types of tests plays an important role in the advancement of the field of precision medicine.

Read more at US Food and Drug Administration.

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