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Variety of NGS Testing Stakeholders Join PrecisionFDA Community at Beta Release

NEW YORK (GenomeWeb) – A number of companies and research institutes with an interest in next-generation sequencing-based genetic testing have signed up for PrecisionFDA, an online platform launched today as a beta version by the US Food and Drug Administration that allows the scientific community to test and evaluate NGS assays.

According to the FDA's website, community members currently include the National Institute of Standards and Technology, the National Institutes of Health, Illumina, Roche, the Broad Institute, the Garvan Institute, Stanford University, 23andMe, Baylor College of Medicine, Counsyl, Emory Genetics Laboratory, GeneDx, Human Longevity, Intel, Natera, Personalis, SeraCare, the US Centers for Disease Control and Prevention, the White House Office of Science and Technology Policy, the American Heart Association, and DNAnexus, which built the platform on behalf of the agency.

FDA first revealed the web-based portal last month at a public workshop on NGS standards and said it was planning the beta release for today.

In a post on its blog today, DNAnexus said that PrecisionFDA was established to "help advance the regulatory science needed to assess the accuracy of genome tests and software."

"By providing a secure cloud-based platform that is open and transparent to the genomic community, researchers and test developers can explore NGS methodologies in order to spur innovation needed to develop necessary standards," the company said. "PrecisionFDA is a research sandbox that provides the genomics community with a web portal where they can experiment, share data and tools, collaborate, and define standards for evaluating analytical pipelines."

A number of tools and reference datasets are currently available on the platform, including variant calls for the NA12878 HapMap sample by NIST, Illumina, the Broad Institute, and the Garvan Institute; variant calls for the HuRef sample (Craig Venter) by Roche's Bina Technologies; software for simulation and evaluation from Roche; and software for local ancestry analysis from Stanford.