About FDA

Description: PrecisionFDA (see PrecisionFDA Website), scheduled to launch in beta on December 15, 2015, will provide a collaborative research effort to generate knowledge that will inform later regulatory pathway and decision making. Through various stakeholder requirement sessions and webinars, the precisionFDA team has engaged a cadre of twenty two diverse external stakeholder organizations. To-date, these organizations have provided FDA with requirements, tools, reference material (e.g., data, workflows), and have committed to participate at launch. In order to demonstrate the precisionFDA platform, a demo and a soft launch will take place in anticipation of the FDA genomic testing public workshops on November 12 and 13, 2015. After the beta launch in December, the portal software will be available on GitHub and the community will grow and the platform will be hardened and expanded with new data and tools. PrecisionFDA will advance the science in order to develop a community research and development portal that will allow community members to test, pilot, and validate existing and new bioinformatics approaches for processing Next Generation Sequencing (NGS).

Accomplishment: FY15: PrecisionFDA project was kicked off in July 2015. The project had a closed beta launched in November 2015 in order to gather reference data, software and tools to ensure a rich experience for the Community in December. Five of the eight apps were directly uploaded by the community (all tools and data are from the community even if the precisionFDA team uploaded them). In addition, 29 of the 39 files were directly uploaded by the community (all reference files are from the community even if the precisionFDA team uploaded them). The team is preparing for the project Beta launch on December 15, 2015 with over 200 Community Members, 8 reference apps, 39 reference files, a vcf comparator tool and a FASTQ simulator.

2016: PrecisionFDA has accepted over 2,000 new community members, holds over 29 Terabytes of data, has held three challenges and ten app-a-thons and has grown to include a library of more than 59 community apps and 424 datasets. In addition, it now provides the community: Resources for computation and storage for advancement of regulatory science; community challenges; a library of Reference Material, Tools, etc. including community contributions (GA4GH VCF comparison tool, BWA-MEM mapper, GATK 3.5 licensed to precisionFDA, VarSim simulator, RTG Core 3.7 + RTG Tools 3.6, NA12878 NIST, Garvan, and Platinum Genome sequences, etc.), and; the ability to “dockerize” applications for ease of use, transportability and consistency in performance across platforms.

2017: In 2017, PrecisionFDA grew to over 2600 community members representing close to 1,000 contributor organizations, holds over 35 Terabytes of data, held its 4th challenge and has scheduled a challenge for early 2018 on food pathogen detection (a first step into this area), instituted an “Expert of the Month” featuring 3 experts to date, and has gathered requirements from the Centers for adding the capability of securely handling regulatory reviews involving NGS data.