DNAnexus’ FedRAMP-authorized cloud-based platform exemplifies FDA strategy for enhancing the regulatory process through data, technology, and stakeholder engagement.
MOUNTAIN VIEW, Calif. – DNAnexus, Inc., the leader in Enterprise Omics Technology, today announced that the U.S. Food and Drug Administration (FDA) has awarded DNAnexus a five-year, $20 million contract to power the precisionFDA Collaborative Omics Environment in the Cloud. PrecisionFDA has enabled significant advances in regulatory science for Next-Generation Sequencing (NGS)-based drugs and devices, bringing together government, academic, and industry to crowd-source a reference standard approach to the validation of bioinformatics pipelines assessing genomic variation.
PrecisionFDA was launched in December 2015, and through collaborative engagement with regulatory stakeholders in scientific challenges, the site established a gold standard for germline variant comparison. Under this award, DNAnexus, with partner Deloitte, LLC, will use its FedRAMP-authorized platform-as-a-service to enhance precisionFDA capabilities for sponsor-reviewer interaction, add support for multi-omics, and provide a library of analytical, statistical, and machine learning applications, accessible to reviewers and powerful enough for bioinformaticians.
DNAnexus previously developed the precisionFDA Challenge Construction Toolkit that FDA and partners use to design, deploy, and present cloud-based scientific challenges, creating a community of more than 4,000 users across 1,200 government, commercial, academic, patient advocacy, and healthcare organizations. The science-driven applications cover a wide range of bioinformatics topics including: variant calling accuracy; food-borne pathogen and biothreat detection; representation and reproducibility of NGS pipelines; assessment of tumor mutation burden; and use of machine learning and artificial intelligence models using multi-omics data to identify biomarkers and predict brain cancer patient outcomes.
“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,” said Elaine Johanson, Acting Director of Health Informatics within the Office of the Chief Scientist at FDA. “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.”
“Cloud-based technology has the potential to transform FDA’s review process, when provided within the security and control assurances of the FedRAMP-authorized platform,” said Richard Daly, Chief Executive Officer of DNAnexus. “We understand FDA’s evolving needs for data stewardship, security, and quality, and the increasing complexity of bioinformatics in regulatory review. We look forward to our expanded relationship with FDA, extending the use of technology, data, and stakeholder engagement on precisionFDA to enhance the regulatory process and provide better options for patients and healthcare providers.”
DNAnexus, the leader in enterprise omics analysis and data management, serves researchers across a spectrum of industries — government, biopharmaceutical, clinical diagnostics, healthcare, and academic research in 33 countries with compliant protection of data, privacy, and intellectual property. The DNAnexus Platform provides a secure and collaborative environment where genetic and omics data can be combined with clinical data at scale, providing new insights that can lead to improved diagnostics, new targeted therapies and better patient care. For more information on DNAnexus, please visit www.dnanexus.com or follow the company @DNAnexus.
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