precisionFDA Collaborative Omics Environment in the Cloud
The Food and Drug Administration (FDA) plays an integral role in precision medicine initiatives, which foresees the day when an individual's medical care will be tailored in part based on their unique characteristics and genetic make-up. To this end, the FDA is developing the tools, standards, and approaches needed to ensure that genomic tests provide reliable and accurate genetic results. This effort is one part of the FDA's commitment to leverage external resources and expertise to advance regulatory science, the science that is essential for product development and evaluation and which underpins the FDA's regulatory decision-making.
As part of the FDA's effort to enable innovation in genomic testing, FDA is developing precisionFDA, an open-source, cloud-based regulatory science research space in which community members can share data, ideas and methods that advance the use of next generation sequencing (NGS) technology. PrecisionFDA provides the community with a research and development system that will enable researchers and developers to test, pilot, and validate existing and new bioinformatics approaches for processing NGS data. NGS test developers, researchers, and other members of the community can share and cross-validate bioinformatics pipelines and results against reference materials that are provided on the precisionFDA system.
The beta-release of precisionFDA recently became operational. This contract includes the maintenance of the current operational system, as well as enhancements to that system.
FDA requires the IT support services of contractors to maintain and improve the production version of precisionFDA system through the following objectives:
• Maintain and continue the evolution of the online cloud-based production precisionFDA system that is backed by a FedRAMP moderate compliant genomic platform by providing (1) capabilities to advance genomic sequencing research and develop new NGS methods; and (2) flexibility to be adapted and improved, keeping the pace with the rapidly evolving NGS field.
• NGS technologies for the FDA to advance regulatory science and develop regulatory tests.
• A system that can expand to support multi-omics scientific capabilities. The current precisionFDA system is already being used to support challenges in addition to genomics (e.g., proteomics). The FDA envisions adding capabilities to support multi-omics sciences as those disciplines become better defined.
Laurel A Woest, Contract Specialist, Phone 2404027671, Email laurel.woest@fda.hhs.gov - Steven Gagnon, Contracting Officer , Phone 3017964873, Email Steven.Gagnon@fda.hhs.gov
