CDx Capabilities
Overview
To plan and execute a companion diagnostics project, Asuragen assembles a diverse team of scientists, bioinformaticians, regulatory and quality experts, project managers and commercial and operations teams. We work collaboratively with our clients to understand their drug development needs and critical timelines. In focusing on integrating the drug and diagnostic development process and developing tests that robustly and efficiently stratify patients to the most effective treatment, our molecular diagnostic team can offer guidance and best practices for molecular diagnostic development such a multiplexing, platform considerations, and regulatory processes. Our scientists work closely with numerous key opinion leaders across multiple different disease areas including cancer and genetic disorders and thus are on the forefront of understanding the latest developments in diagnosing, monitoring, and treating diseases.
Upon completion of a successful pharmacogenomics development project by Asuragen’s Molecular Services, the facilities and capabilities used in the development of Asuragen’s own diagnostic assays are available for the development, manufacture, and commercialization of custom companion diagnostics. As an FDA registered contract manufacturer, Asuragen offers custom cGMP development and manufacturing services. In addition, Asuragen has worldwide commercialization capabilities through our direct sales force and distributor networks who are already established at top academic and national laboratories in the US and Europe. Asuragen also has a CAP-accredited, CLIA laboratory that can be selected to perform diagnostics tests to support the timely commercial launch of the drug and companion diagnostic.