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Enables the CRO to deliver clinical-grade testing on human specimens.
July 23, 2025
By: Charlie Sternberg
U.S.-headquartered CRO Crown Bioscience’s San Diego laboratory has received Clinical Laboratory Improvement Amendments (CLIA) certification. This milestone enables Crown Bioscience to deliver clinical-grade testing, strengthening its support for clients’ clinical and translational drug development efforts.
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.
“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.”
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.
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