The Food and Drug Administration is launching a new, open-source platform to allow community sharing of genomic information. It’s called precisionFDA, and will be the newest cog in the White House’s Precision Medicine Initiative.
It’s planned for beta release in December this year, and is being developed by Bay Area startup DNAnexus. In a blog, DNAnexus outlined the workflow for precisionFDA in the infograph seen above.
The new platform is meant to help researchers evaluate next generation sequencing technologies used in diagnostic tests. There can be open collaboration around the tests’ accuracy and reproducibility. It’ll also help the scientific community crowdsource reference datasets, and importantly, help guide federal regulators in building out policy for NGS technology.
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It’s tough, after all, to establish regulatory guidelines for diagnostic tests that use next-generation sequencing. Most diagnostic tests on the market evaluate a patient for one outcome alone, but NGS tests can actually generate far more patient data than is needed for a single test.
Harnessing this data for other purposes could be wildly helpful in understanding the genome better, which is a key driver for the Precision Medicine Initiative. Regulators think this open-sourced platform will provide enough checks-and-balances validation to show the NGS tests meet certain standards of quality. It should also help provide information to help in security, privacy and governance audits. In essence, this should help democratize the regulatory process for NGS-based diagnostics applications.
Dr. Taha Kass-Hout, the FDA’s Chief Health Informatics Officer, and Dr. David Litwack, an FDA policy advisor in diagnostics and radiological health, wrote in the FDA Voice blog about the rollout of precisionFDA:
Initially, precisionFDA’s public space will offer a wiki and a set of open source or open access reference genomic data models and analysis tools developed and vetted by standards bodies, such as the National Institute of Standards and Technology (e.g.,Genome in a Bottle). We believe precisionFDA will help us advance the science around the accuracy and reproducibility of NGS-based tests, and in doing so, will advance consumer safety.
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Users will likely span the precision medicine continuum — including next-gen sequencing testmakers, biopharma companies, hospitals and healthcare providers, research consortia and patient advocacy groups.
