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2015.08.06

FDA to develop precision-medicine platform

The Food and Drug Administration is developing an open-source, cloud-based software platform that will allow for collaborative sharing of information among genomic researchers as part of President Barack Obama's Precision Medicine Initiative.

The agency plans to release a beta version of the platform, named precisionFDA, by December. The goal is that the software allows users to create an informatics community where researchers can store and share their work with collaborators.

Users will have secure access to independent work areas where they can choose to have their software code or data kept private or shared with fellow researchers, the FDA or the public.

In a blog posted on the agency's website Wednesday, FDA Chief Health Informatics Officer Dr. Taha Kass-Hout and David Litwack, FDA policy adviser, wrote that having a collaborative approach in the area of genetic testing was the most effective way of advancing the president's effort to promote the advancement of precision medicine. Obama sees it as a means of improving medical treatments for all by tailoring therapies to individual patients.

“We believe precisionFDA will help us advance the science around the accuracy and reproducibility of NGS (next generation sequencing)-based tests, and in doing so, will advance consumer safety. We look forward to continuing to update the community on the development of these new tools,” Kass-Hout and Litwack wrote.

While many see precision medicine as the most viable option toward making progress against such difficult-to-treat conditions such as cancer and Alzheimer's, some contend enthusiasm over the personalized approach may be premature.

In an article published Thursday in the New England Journal of Medicine, public health scholars argued that the increased focus on precision medicine distracts from making broader investments that could have a significant impact toward improving population health.

“There is now broad consensus that health differences between groups and within groups are not driven by clinical care, but by social-structural factors that shape our lives,” wrote Dr. Sandro Galea, dean of the Boston University School of Public Health, and Ronald Bayer, professor of Sociomedical Sciences and co-director of the Center for the History and Ethics of Public Health at Columbia University's Mailman School of Public Health. “Yet seemingly willfully blind to this evidence, the United States continues to spend its health dollars overwhelmingly on clinical care.”