DNAnexus, the global leader in biomedical informatics and data management, 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.
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.
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.
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.