PrecisionFDA Launched With Promise of Transparency and Quality Care

The vision for a medical system that would eliminate experimentation with different drugs and where the physician would have tools at hand to deliver a precise treatment plan, is now a step closer to being achieved. The FDA, today, launched the beta version of precisionFDA, a cloud-based platform that members can utilize to access and share data sets, analysis pipelines, and bioinformatics tools, to further their own research and support decisions when using next generation sequencing (NGS).

According to the website, the dynamic and rapidly growing community of precisionFDA includes:

· Genome test or software providers

· Standards-making bodies

· Pharmaceutical and biotechnology companies

· Healthcare providers

· Academic medical centers

· Researchers

· Patients

· FDA and other government agencies

In a blog describing the initiative, 2 of the architects of the tool Taha A. Kass-Hout, MD, MS, and Elaine Johanson, describe the initiative and its potential. This data-sharing platform will open up a world of opportunities for collaborations that will ultimately translate into information on a person’s health status, risk of disease, and possible responses to treatment, they write. Additionally, the platform will allow users to compare their results against previously validated reference results on genomic tests, as well as obtain feedback. To encourage data transparency, FDA plans to place the code for precisionFDA on the largest open source software repository, GitHub.

The Personalized Medicine Coalition (PMC) has applauded the FDA’s efforts. In a statement released today, Daryl Pritchard, PhD, vice president of science policy at PMC, said, “PrecisionFDA is an encouraging effort to engage the personalized medicine community in FDA's decision-making processes. We hope stakeholders will use it and participate in its continued development. We look forward to working with FDA as the agency continues to consider the implications of various approaches to NGS oversight.”