Agilent Technologies Inc., has announced the launch of its Biopharma CDx Services Lab (BCSL) in Carpinteria, California, US following receipt of California State clinical laboratory license and Clinical Laboratory Improvement Amendments (CLIA) certificate of compliance.
These credentials signify that the lab operates in accordance with CLIA regulations, which are federal standards applicable to all US facilities testing human specimens for health assessment, diagnosis, prevention, or treatment of diseases. The CLIA certificate of compliance ensures high standards for accuracy and reliability in laboratory testing, confirms regulatory adherence, boosts market credibility, and improves operational efficiency.
The BCSL and Agilent’s assay development model will support drug development from early clinical studies through regulatory approval with efficient, flexible, and streamlined companion diagnostic development. The BCSL will also provide access to innovative technologies for biomarker assessment with novel precision therapeutics in clinical trials, as well as high-quality assays that deliver robust data. The continuous development model from feasibility through US FDA approval of companion diagnostics offers significant cost and time advantages to biopharma seeking to maximize the value of their investment in companion diagnostics and precision therapeutics.
