FDA Announces PrecisionFDA Platform
By Christine Kern, contributing writer
Crowd-sourced, cloud-based platform allows researchers to test, pilot, and validate new approaches.
Together with DNAnexus, the FDA announced the creation of PrecisionFDA, a new informatics community and supporting platform that allows researchers to test, pilot, and validate new approaches as part of the Precision Medicine Initiative.
In his State of the Union Address, President Barack Obama called for an initiative to fund precision medicine to help achieve cures for genetic conditions such as cancer and diabetes. Precision medicine, also known as “personalized medicine,” leverages the knowledge we’ve gained by sequencing the human genome into better, more effective medicines, as Health IT Outcomes reported.
According to the FDA blog, “To begin to realize this new vision, PrecisionFDA is designed as a crowd-sourced, cloud-based platform to advance the science needed to develop the necessary standards. PrecisionFDA will supply an environment where the community can test, pilot, and validate new approaches. For example, 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.”
The platform in anticipated to be ready for release in December 2015 and will offer a secure and independent research area for community members to work. The public space on PrecisionFDA will also offer a wiki and a set of open source or open access reference genomic models and analysis tools.
DNAnexus has been contracted to build the open source platform, which “is a new approach for evaluating bioinformatics workflows, and is an integral part of FDA’s work in better understanding diagnostic tests that incorporate next-generation sequencing (NGS) technologies,” according to a DNAnexus statement.
“The DNAnexus Platform will provide the underlying cloud-based compute and data management infrastructure. In addition, DNAnexus will work with the FDA to build a community around its informatics platform to help drive standards around secondary analysis, the process of mapping, alignment, and variant calling of DNA sequence data,” the statement explained.
Among the key objectives for PrecisionFDA are:
- Using a cloud-based portal, PrecisionFDA, to create a community around open-source genomic analysis pipelines, reference data, and analytical processing resources.
- Balancing levels of security, privacy, and governance control to ensure the protection of collaborators’ intellectual property and protected information, with interaction within the community.
- Providing an initial set of reference genomic data models and reference analysis pipelines.
Providing independent genomic analysis and data management work areas that can be kept private or shared with owner’s choice of collaborators, the public, or FDA for vetting or validation.