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/.
About DNAnexus
DNAnexus combines expertise in cloud computing and bioinformatics to create the global network for genomic medicine. DNAnexus provides security, scalability and collaboration for enterprises and organizations that are pursuing genomic-based approaches to health in order to accelerate medical discovery. DNAnexus is supporting customers around the world that are tackling some of the most challenging and exciting opportunities in human health. For more information, please visit: https://dnanexus.com and follow us at @DNAnexus.
Contacts
Element Public Relations, for DNAnexus
Tim Smith, 415-350-3019
tsmith@elementpr.com
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