FDA has an important role to play in President Obama’s Precision Medicine Initiative, which aims to deliver medical care tailored to the patient’s unique genetic make-up. As part of that role, the agency has launched precisionFDA, the cloud-based platform and an environment “where the community can test, pilot, and validate new approaches.” For example, next generation sequencing (NGS) test developers, researchers, and other members of the community can share and cross-validate their tests or results against crowd-sourced reference material in precisionFDA.
NGS tests may be used in many ways in the clinic and can produce an unprecedented amount of data about a patient. To tackle that challenge, precisionFDA will be requiring each NGS test developer to show that the test meets certain standards for quality. Similarly, to demonstrate a test’s clinical value, FDA will be assessing whether it may be more efficient for developers to refer to evidence in well-curated, validated, and shared databases of mutations instead of independently generating data to support a mutation-disease association.
The platform will be released in beta in December 2015, offering access to secure and independent work areas where developers can keep their software code or data private, or share it with collaborators, FDA, or the public. Initially, precisionFDA’s public space will offer a wiki and a set of open source or open access reference genomic data models and analysis tools developed and vetted by standards bodies, such as the National Institute of Standards and Technology. FDA hopes that precisionFDA will help advance the science around the accuracy and reproducibility of NGS-based tests, and in doing so, will advance consumer safety.