[4][5] PrecisionFDA connects experts, citizen scientists, and scholars from around the world and provides them with a library of computational tools, workflow features, and reference data.
[8] The platform also features a crowdsourcing model to sponsor community challenges in order to stimulate the development of innovative analytics that inform precision medicine and regulatory science.
[16] The Brain Cancer Predictive Modeling and Biomarker Discovery Challenge, run in collaboration with Georgetown University, asked participants to develop machine learning (ML) and artificial intelligence (AI) models to identify biomarkers and predict brain cancer patient outcomes using gene expression, DNA copy number, and clinical data.
PrecisionFDA challenges have led to meaningful regulatory science advancements, including published best practices for benchmarking germline small-variant calls in human genomes.
In August 2016, precisionFDA launched App-a-Thon in a Box, which aimed to encourage the creation and sharing of Next Generation Sequencing (NGS) apps and executable Linux command wrappers.
[19] In 2018, the DNAnexus platform, which is leveraged by precisionFDA, was granted Authority to Operate (ATO) by Health and Human Services (HHS) for FedRAMP Moderate.
[4][5] PrecisionFDA is available to all innovators in the field of multi-omics, including members of the scientific community, diagnostic test providers, pharmaceutical and biotechnology companies, and other constituencies such as advocacy groups and patients.
To get involved, visit precision.fda.gov and request access to become a member of a growing community that is informing the evolution of precision medicine, advancing regulatory science, and enabling improvements in health outcomes.