By Kelly A. Briganti, Editorial Director, G2 Intelligence
The U.S. Food and Drug Administration (FDA) has announced the development of precisionFDA, “an informatics community and supporting platform” to assist efforts to maximize the potential of genetic information. The FDA plans to launch the platform in December via a beta release and describes it as a “crowd-sourced, cloud-based platform to advance the science needed to develop the necessary standards” for evaluating next-generation sequencing (NGS) tests.
The platform will allow participants to share software code or data either with the public or select entities of their choosing in a secure environment. The publicly accessible space will begin with a wiki and “a set of open source or open access reference genomic data models and analysis tools.”
The same day as the FDA announcement, DNAnexus announced it received a research and development contract from the FDA’s Office of Health Informatics to develop precisionFDA. The DNAnexus press release says the company anticipates users of precisionFDA will include “NGS-based test providers, standards-making bodies, pharmaceutical and biotechnology companies, health care providers, academic medical centers, research consortia and patient advocacy groups.” DNAnexus explains that the platform will assist the FDA in its regulatory role of overseeing the quality of diagnostic tests utilizing NGS technology and allows test developers to “independently evaluat[e] the accuracy and reproducibility of NGS analysis workflows,” and share results with the FDA and others, “addressing the critical need for convenient, reproducible comparisons between results derived from the same biospecimen.”