News

FDA launches precisionFDA, a cloud-based genomics portal for NGS research

FDA launches precisionFDA, a cloud-based genomics portal for NGS research

WASHINGTON – In ongoing work to create a robust community for research as part of the Precision Medicine Initiative, the U.S. Food and Drug Administration announced in mid December the launch of precisionFDA, an online portal intended to foster collaboration among researchers using next generation sequencing technologies.

According to information at healthcare.gov, precisionFDA provides a secure, cloud-based environment where researchers can conduct genome analysis comparison against reference material, and a community area where they can publish and share results, reference materials, and tools.

A blog post at fda.gov by Taha A. Kass-Hout, MD, MS, FDA’s chief health informatics officer and Elaine Johanson, project manager for precisionFDA, noted the portal intends to add the growing base of knowledge of genetic variation to advance the delivery of highly individualized treatments for patients. “The precisionFDA platform is a part of this larger effort and through its use we want to help scientists work toward the most accurate and meaningful discoveries. precisionFDA users will have access to a number of important tools to help them do this. These tools include reference genomes, such as “Genome in the Bottle,” a reference sample of DNA for validating human genome sequences developed by the National Institute of Standards and Technology,” Kass-Hout and Johanson wrote in the blog.

The FDA is openly seeking feedback and help to hone development of precisionFDA to improve usability and transparency. To do this, the FDA has placed the code for precisionFDA on open source software repository, GitHub, to provide users with the ability to continually improve its features. The new portal leverages the success and learnings from the launch of openFDA, an online community launched in 2014 that provides easy access to FDA’s public data sets. Since it’s launch, openFDA has already resulted in novel ways to use, integrate and analyze FDA safety data.

“We’re confident that employing such a collaborative approach to DNA data will yield important advances in our understanding of this fast-growing scientific field, information that will ultimately be used to develop new diagnostics, treatments and even cures for patients,” the blog post noted.

Participants in the precisionFDA community come from a broad swath of business and industry including pharma companies, genomic testing and informatics providers, healthcare providers, academic medical center and patients, among others.

While not a regulatory arm of FDA, the agency anticipates that information generated by the effort will help inform future regulatory pathways and decision making.