DNAnexus, the global leader in biomedical informatics and data management, today announced the availability of its Clinical Trial Solution (CTS) which streamlines the use of next-generation sequencing (NGS) data in regulated clinical trials. The company also announced Almac Diagnostics, a global precision medicine company, as one of the first customers of the service.
Almac Diagnostics has expertise in the development of biomarker assays for commercial partners across a wide range of technologies and has an extensive track-record in validating assays across key regulatory standards, including; CLIA, CLEP, CE-IVD and FDA.
The DNAnexus cloud-based CTS enables the use of genomic and other -omic information in combination with trials data, to reduce the time and cost of clinical development, and improve trial results and patient care.
Bringing a single oncology drug through FDA approval can take over a decade and cost more than $1 billion. By investing in NGS in early-stage clinical development, later phases can be optimized and de-risked through biomarker-driven participant selection and intervention guidance. The DNAnexus CTS combines secondary analysis, interpretation, and translational informatics solutions, on a GxP-compliant, quality managed, audit-friendly, cloud-based Platform-as-a-Service. The same compliant DNAnexus service powers the FDA’s precisionFDA platform for advancing regulatory standards for NGS-based drugs and devices.
“Genomic-based clinical trials are critical in identifying patient populations most likely to benefit from a targeted treatment,” said Dr. Timothy Davison, VP of Data Sciences & Biostatistics, Almac Diagnostics. “The process of developing and validating a biomarker into a test fit for clinical delivery is complex. DNAnexus offers the industry’s most comprehensive security and privacy framework, which provides our global labs auditability, data immutability, and scalability to implement a streamlined integration of genome-based biomarker delivery in clinical trials.”
“Pharmaceutical companies and their research partners are looking for ways to incorporate human genome and microbiome-based insights into their clinical trial designs, and have been frustrated with the cost and time to deploy and operate GxP-compliant systems to manage high-throughput genomics data,” said Richard Daly, CEO of DNAnexus. “The DNAnexus Clinical Trial Solution enables our customers to rapidly integrate genomics into adaptive trial design and significantly improve outcomes, ensuring consistency and reproducibility of results across geographical regions and research partners.”
Deploying, qualifying, and validating bioinformatic tools for genomic data analysis, and operating GxP-compliant services, are specialized tasks that are required for discovery and use of genomics-based insights in clinical trials. The DNAnexus CTS enables biopharmaceutical companies to transition validated NGS pipelines from translational research into clinical development and, for approved drugs and devices, into clinical and companion diagnostics, all in compliance with HIPAA, CAP/CLIA, and GxP regulations.