Quantcast

Industry news that matters to you.  Learn more

DNAnexus to Deliver precisionFDA

Reading time: 2 minutes

DNAnexus, the leader in cloud-based genome informatics and data management, today announced that the company was awarded a research and development contract by the U.S. Food and Drug Administration’s Office of Health Informatics to build precisionFDA, an open source platform for community sharing of genomic information.

precisionFDA is a new approach for evaluating bioinformatics workflows, and is an integral part of the agency’s work in understanding diagnostic tests that incorporate next generation sequencing (NGS) technologies. FDA’s role under the White House’s Precision Medicine Initiative is to review the current regulatory landscape and develop a streamlined approach to evaluating NGS-based diagnostics. precisionFDA is being developed to offer test developers a flexible method for independently evaluating the accuracy and reproducibility of NGS analysis workflows, and to securely share results with collaborators and the FDA. precisionFDA will also support community efforts to crowdsource reference datasets, addressing the critical need for convenient, reproducible comparisons between results derived from the same biospecimen.

DNAnexus expects that the platform will be broadly used by NGS-based test providers, standards-making bodies, pharmaceutical and biotechnology companies, health care providers, academic medical centers, research consortia, and patient advocacy groups.

“DNAnexus is proud to be delivering precisionFDA and creating a community around open-source genomic analysis pipelines, reference data, and analytical processing resources,” said Richard Daly, CEO of DNAnexus. “The FDA has taken a leadership position in making President Obama’s Precision Medicine Initiative a reality, and the DNAnexus platform will enable the managing and sharing of genomic data at an unprecedented level.”

Technical information on precisionFDA can be found on the DNAnexus blog. For more information on the FDA’s perspective on precisionFDA, visit http://blogs.fda.gov/fdavoice/index.php/2015/08/advancing-precision-medicine-by-enabling-a-collaborative-informatics-community/.

Source: Business Wire