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Nine challenges FDA wants scientists to solve for NGS-based diagnostics

April 21, 2016 7:00 AM UTC

FDA has grasped the nettle and addressed one of the thorniest challenges arising out of the proliferation of studies using or planning to use next-generation sequencing (NGS) for precision medicine: how to make sense of the wealth of data for use in the clinic. The agency has corralled stakeholders and produced a manifesto for the steps needed to translate the data dumps into regulated diagnostics.

On April 20, the agency published a "roadmap" Perspective in Science Translational Medicine laying out the challenges it believes are slowing the adoption of NGS for routine clinical use, and proposing a series of key questions to be addressed by regulatory scientists. The Perspective was a joint publication, co-authored by representatives from the Center of Excellence in Regulatory Science and Innovation (CERSI) at Stanford University and the University of California San Francisco, the NIH's National Institute of Standards and Technology (NIST) and the bioinformatics company DNAnexus Inc...