BRISBANE, Calif. and MOUNTAIN VIEW Calif., Aug. 6, 2015 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of actionable diagnostic surveillance solutions for organ transplant recipients, and DNAnexus Inc., the leader in cloud-based genome informatics and data management, today announced that CareDx has selected DNAnexus' cloud genomics platform to support its ongoing R&D activities as well as clinical trials and registries. The platform has also been selected for the release of the CareDx analytically validated cell-free DNA (cfDNA) assay to be available from its CLIA laboratory later this year.
"The DNAnexus platform made it easy for us to take advantage of cloud genomics and reduced the cost, time, and technical challenges we would have faced in building an on-premise solution to meet our diverse R&D activities," said John J. Sninsky, Ph.D., Chief Scientific Officer of CareDx. "The HIPAA-compliant DNAnexus platform provides seamless and secure integration for our proprietary Next Generation Sequencing (NGS) cfDNA transplant assay. In addition, the platform offers rapid implementation of a computational analysis solution, which was critical for our cfDNA D-OAR heart transplant registry and DART kidney transplant clinical trial."
CareDx is dedicated to improving the lives of organ transplant patients through high clinical impact, non-invasive diagnostics. By combining the latest advances in genomics and bioinformatics technology, with a commitment to generating high-quality clinical evidence through trials and registries, CareDx strives to stay at the forefront of organ transplant surveillance solutions. Together, the DNAnexus and CareDx teams completed the respective organizational 'dry lab' verifications for the ongoing CLIA laboratory validation of the cfDNA test.
"We believe the cloud is the most secure place for genomic data and the only technology capable of keeping pace with the growth of the clinical diagnostics market," said Richard Daly, CEO of DNAnexus, "The recent precisionFDA initiative demonstrates the critical role that the cloud and the diagnostic market play in the world of genomics. We are pleased to collaborate with CareDx as they expand upon their industry-leading organ transplant surveillance solutions and embark upon additional clinical opportunities to improve the management of transplant patients."
"The clinical informatics infrastructure for our FDA-cleared AlloMap™ gene expression profiling algorithm provided the foundation for our NGS cfDNA assay," commented Dave Wexler, Ph.D., Senior Director, Clinical Informatics and Automation Engineering of CareDx. "However, we needed to rapidly implement a production ready solution to accelerate our cfDNA computational analysis. The compliant cloud-based DNAnexus platform, with full versioning and auditing will play a critical role in expediting our cfDNA assay efforts, enabling us to deliver our novel surveillance management solution to the transplant setting and scale our NGS offerings in the future."
CareDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value, non-invasive diagnostic surveillance solutions for transplant recipients. The Company has commercialized AlloMap®, a gene expression test that aids clinicians in identifying heart transplant recipients with stable graft function who have a low probability of moderate/severe acute cellular rejection. CareDx is also pursuing the development of additional products for post-transplant monitoring of other solid organs that use a variety of technologies, including next generation sequencing to detect donor-derived cell-free DNA to monitor the health of organs after transplantation. The Company is currently investigating a research use only donor-derived cell-free DNA-based test for heart transplant recipients. For more information, please visit: www.CareDx.com.
DNAnexus accelerates the development and delivery of genomic medicine with the global network for sharing and managing genomic data and tools. DNAnexus provides a technology infrastructure and toolset that is optimized for addressing the challenges of security, scalability, and collaboration, for organizations that are pursuing genomic-based approaches to health, in the clinic and in the research lab. The DNAnexus team is made up of experts in computational biology and cloud computing who are working with organizations to tackle some of the most exciting opportunities in human health, making it easier—and in many cases feasible—to work with genomic data. With DNAnexus, organizations can stay a step ahead in leveraging genomics to achieve their goals. The future of human health is in genomics. DNAnexus brings it all together. For more information please visit: https://dnanexus.com and follow us on Twitter @DNAnexus.
Forward Looking Statements
This press release contains forward-looking statements including, but not limited to statements regarding the Company's expectations regarding future potential, development and commercial activities. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward looking statements, including CareDx's limited operating history and experience with developing new markets; risk relating to new partnerships and commercialization of those relationships, as well as other risks stated in CareDx's filings with the SEC located at www.sec.gov. CareDx disclaims any obligation to publicly update or revise any forward looking statements to reflect events that occur or circumstances that exist after the date on which they were made.
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