Crown Bioscience San Diego achieves CLIA certification to enhance clinical trial support

Crown Bioscience to deliver clinical-grade testing, further strengthening its support for clients' clinical and translational drug development efforts

25 Jul 2025

Industry news

Crown Bioscience has announced that its San Diego laboratory has received Clinical Laboratory Improvement Amendments (CLIA) certification.

CLIA, regulated by the Centers for Medicare and Medicaid Services (CMS), sets rigorous federal standards for accuracy, reliability, and quality laboratory operations. With this designation, Crown Bioscience’s San Diego facility affirms full compliance, providing clients with increased confidence in the biomarker data used for clinical decision-making and regulatory submissions.

As a CLIA-certified laboratory, Crown Bioscience is now equipped to conduct clinical testing on human specimens, a key component of advancing oncology research and personalized medicine. This designation strengthens the company’s position as a trusted partner capable of meeting specialized project needs throughout all stages of drug development.

"Achieving this marks a crucial step in our commitment to delivering high-quality, compliant laboratory services," said Julie Mayer, Vice President, Global Biomarker Platform at Crown Bioscience. "This enables us to expand our offerings by leveraging CLIA certification to support our partners in accelerating their clinical development and regulatory approval timelines."

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BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.Clinical TrialsCancer ResearchCancer research aims to understand the mechanisms of cancer development and progression to improve prevention, diagnosis, and treatment. From molecular biology to clinical trials, research spans a wide range of disciplines, including immunotherapy, targeted therapies, and drug discovery. Explore the best cancer research products in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.CLIA
Crown Bioscience San Diego achieves CLIA certification to enhance clinical trial support