FDA Unveils Next-Gen DNA Sequencing Portal: precisionFDA

By Jof Enriquez,
Follow me on Twitter @jofenriq

In its bid to advance President Obama's precision medicine initiative, the U.S. Food and Drug Administration (FDA) has launched precisionFDA – an online, cloud-based portal where scientists from industry, academia, government can collaborate and share data on next-generation DNA sequencing (NGS).

Laboratories can utilize NGS to collect vast amounts of genomic data and reveal insights to the causes of diseases, as well as potential treatments. Because people have different genomic profiles, scientists believe that medical treatments and drugs are more effective if tailor-made for each patient, versus a "one-size-fits-all" treatment approach. FDA recognizes the potential of NGS technology to advance personalized medicine, and had already approved a handful of NGS devices to market. Now, the agency takes its support one step further by launching precisionFDA.

Through this beta-launched platform, FDA says in a blog post that it wants "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."

This online community will allow scientists from academia, industry, and government to share reference results of genome analyses with peers, and to hopefully "improve the quality and accuracy of genomic tests – work that will ultimately benefit patients." Moreover, users can access the code of precisionFDA that is to be housed in the online software repository service GitHub, giving the opportunity to enhance further the platform's features, according to FDA.

Members of the growing precisionFDA community include genome test or software providers, standards-making bodies, pharmaceutical and biotech companies, providers, academic medical centers, researchers, patients, FDA, and other government agencies.

"PrecisionFDA provides the genomics community with a secure, cloud-based platform where participants can access and share datasets, analysis pipelines, and bioinformatics tools, in order to benchmark their approaches and advance regulatory science," the precisionFDA website explains. “While precisionFDA does not serve a regulatory role, it is expected to generate knowledge to inform future regulatory pathways and decision making,” according to FDA.

In rolling out the precisionFDA platform, FDA says it leveraged its experience with openFDA, a free-to-use website launched in 2014 that contains structured datasets – including adverse events, recalls, and documentation – which can be freely accessed by the public.

The Personalized Medicine Coalition commended FDA for engaging with stakeholders as it decides whether and how to use curated databases for regulatory oversight of NGS technologies, according to RAPS.

“We hope stakeholders will use it and participate in its continued development,” Daryl Pritchard, PhD, VP of Science Policy at the Personalized Medicine Coalition, said in a statement, according to Health IT Analytics. “We look forward to working with FDA as the agency continues to consider the implications of various approaches to NGS oversight. Keeping up with scientific advancements in personalized medicine is difficult, but FDA is addressing the challenge.”