The QMN Weekly Bulletin

FDA Introduces New precisionFDA Online Portal for NGS Analysis

Feb. 19, 2016

The FDA is hoping to improve the quality and accuracy of genomic tests through the launch of a new online portal that will allow for collaboration on developing the science behind next-generation sequencing.

Users of precisionFDA will have access to a reference sample of DNA for validating human genome sequences developed by the National Institute of Standards and Technology. The platform also provides a private area to conduct genome analysis and comparison against reference material, as well as a community area to publish and share results.

Launched in mid-December, the initiative could one day enable doctors to diagnose, treat or cure patients based on their genes, say Taha Kass-Hout, director of the FDA’s Office of Health Informatics, and precisionFDA project manager Elaine Johanson in an FDAVoice blog post.

In the coming months, the FDA will engage users in improving the usability, openness and transparency of precisionFDA, including by placing the code for the portal on the world’s largest open source software repository, GitHub.

The FDA sits on a vast mountain of data that potentially could be useful in the future of new drug development, repurposing existing products and resurrecting molecules currently on the shelf, says Peter Pitts, president of the Center for Medicine in the Public Interest.

“If the agency database can indeed be made available, it’s a step in the right direction. We’ll never know unless we try — and that’s precisely what the FDA is facilitating,” he says.

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