CareDx, Inc., a molecular diagnostics company focused on the discovery, development and commercialisation of actionable diagnostic surveillance solutions for organ transplant recipients, has selected DNAnexus Inc's cloud genomics platform to support its ongoing R&D activities as well as clinical trials and registries.
DNAnexus is a leader in cloud-based genome informatics and data management. 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 organisational '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, chief executive officer of DNAnexus.
"The recent precision FDA 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."