Agilent Technologies Inc., (NYSE: A) today announced the launch of its Biopharma CDx Services Lab (BCSL) in Carpinteria, California, following receipt of California State clinical laboratory license and Clinical Laboratory Improvement Amendments (CLIA) Certificate of Registration*.
These credentials signify that the lab operates in accordance with CLIA regulations, which are federal standards applicable to all U.S. facilities testing human specimens for health assessment, diagnosis, prevention, or treatment of diseases. The CLIA Certificate of Registration 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 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.
“Agilent is committed to advancing the frontiers of biopharma and clinical diagnostics. The launch of the Biopharma CDx Services Lab represents a significant milestone in the company’s mission to support the development of innovative therapeutics and precision medicine,” stated Nina Green, vice president and general manager of Agilent’s Companion Diagnostics (CDx) Division. “By providing cutting-edge technologies and high-quality assays, Agilent aims to streamline the path from early clinical studies to FDA approval, accelerating the delivery of life-changing treatments to patients.”
Launching the BCSL is a key element in Agilent’s broader strategic commitment to the biopharma, clinical diagnostics, and precision medicine sectors. It strengthens the company’s capabilities in early assay development, technology innovation, and prospective clinical trial patient testing, while underscoring Agilent’s dedication to being a trusted partner in the biopharma industry and shaping the future of healthcare.
* Update on September 20, 2024: “certificate of compliance” was corrected to “Certificate of Registration”. Certificate of Registration is an achievement step in the process to receiving a Certificate of Compliance.