NEW YORK – The US Food and Drug Administration has awarded a five-year, $20 million contract to the team of DNAnexus and Deloitte to run the collaborative omics environment for the PrecisionFDA cloud-based next-generation sequencing platform.
San Francisco-based DNAnexus has been leading the development of the PrecisionFDA data platform since 2015.
As part of the new contract, which DNAnexus announced Tuesday, the company and its partner Deloitte will add support for multi-omics data and provide a series of cloud-based analytical, statistical, and machine learning applications to the PrecisionFDA platform.Â
"Recent scientific and biomedical advances in precision medicine are driving cloud-based data and technology strategies, closing the gap in our ability to translate advances into clinically validated diagnostics and therapeutics," Elaine Johanson, acting director of health informatics in FDA's within the Office of the Chief Scientist, said in a statement. "PrecisionFDA contributes to an optimized and independent review process by making tools available that empower reviewers to assess the accuracy of analytic pipelines without requiring bioinformatics expertise and enabling effective sponsor-reviewer interaction on a secure, cloud-based platform."
DNAnexus CEO Richard Daly said that the new contract demonstrates his company's understanding of "FDA's evolving needs for data stewardship, security, and quality, and the increasing complexity of bioinformatics in regulatory review." He said that the expanded relationship will help PrecisionFDA "enhance the regulatory process and provide better options for patients and healthcare providers."