FDA issues new guidance on next generation sequencing
pharmafile | July 7, 2016 | News story | Medical Communications, Research and Development | FDA, next generation sequencing, precision medicines initiative
The US Food and Drug Administration (FDA) has issued new draft guidance, as part of the Precision Medicine Initiative, on next generation sequencing as the regulator gears up for the next wave of innovation within the health tech sphere.
Next generation sequencing is the method whereby a person’s DNA can be scanned to detect genomic variations that may determine whether a person is at risk of disease or may help to inform treatment decisions.
Current regulations and guidance may be relevant for conventional diagnostics but the scope of this new technology to examine millions of DNA variants at a time requires a flexible approach to oversight that is adapted to the novel nature of these tests, according to the FDA.
Commissioner Robert Califf says: “Targeting the right treatments to the right patients at the right time is the goal of the President’s Precision Medicine Initiative. Soon, patients will have a much more complete picture of their health than in the past, informed by their genetic and genomic makeup. The FDA is preparing for this exciting approach at multiple levels.”
The two sets of guidance – “Use of standards in FDA’s regulatory oversight of next generation sequencing-based in vitro diagnostics used for diagnosing germline diseases” and “Use of public human genetic variant databases to support clinical validity for next generation sequencing-based in vitro diagnostics” – seek to ensure the accuracy and usefulness derived from this dynamic new technology, and that it remains flexible and adaptable to the changing conditions.
The Precision Medicines Initiative was launched by the Obama administration in early 2015, with the FDA taking a foundational role in the process. The FDA indicates that it encourages public comments on the draft guidance during the 90-day comment period.
Francis Collins, director of the National Institutes of Health (NIH), comments: “The draft guidance are an important step in the development of NGS-based tests. NIH sees great value in these guidances and encourages test developers to adopt the best practices outlined so that high quality tests can become available to the patients who need them.”
Sean Murray
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