Crown Bioscience, a global contract research organization (CRO) and a JSR Life Sciences company, today announced that its San Diego laboratory has achieved College of American Pathologists (CAP) accreditation. This milestone builds on the site’s Clinical Laboratory Improvement Amendments (CLIA) certification, obtained in July 2025, further strengthening its ability to deliver clinical-grade biomarker testing to support regulated drug development programs.
CAP accreditation is recognized as a leading benchmark for laboratory quality, reflecting rigorous standards for operational excellence, technical competence, and quality oversight. Together with CLIA certification—regulated by the U.S. Centers for Medicare & Medicaid Services—these credentials confirm the San Diego laboratory’s compliance with federal requirements for clinical testing on human specimens and its readiness to support biomarker analyses aligned with clinical trial and regulatory expectations.
“Achieving CAP accreditation, following CLIA certification, is a significant step in the continued expansion of our global biomarker capabilities,” said Julie Mayer, Vice President, Global Biomarker Platform. “With these accreditations in place at our first U.S.-based laboratory, we are better positioned to support clinical trials with high-quality, reliable data and help our partners advance innovative therapies more efficiently toward patients.”
“As studies transition from translational research into the clinic, quality systems and regulatory alignment become increasingly critical,” said Maria Radino, Vice President, Global Quality and Regulatory Compliance at Crown Bioscience. “CAP and CLIA accreditation at our site reflects the robustness of our quality framework and reinforces our commitment to generating data that customers can rely on with confidence as they progress into clinical development.”
With these accreditations, Crown Bioscience’s San Diego laboratory enables closer integration of biomarker testing across preclinical and clinical workflows, supporting continuity of data and alignment with regulatory requirements throughout development.
This achievement further strengthens Crown Bioscience’s growing global network of accredited and certified laboratories, reinforcing its role as a trusted partner to biotechnology and pharmaceutical companies advancing oncology and precision medicine programs. For more information about Crown Bioscience’s laboratory services and quality credentials, visit www.crownbio.com.
About Crown Bioscience
Crown Bioscience, a JSR Life Sciences company, is a global contract research organization (CRO) dedicated to accelerating drug discovery and development in oncology and immuno-oncology. We partner with biotech and pharmaceutical companies to provide innovative, tailored solutions spanning preclinical research, translational platforms, and clinical trial support. With the world’s largest commercially available patient-derived xenograft (PDX) collection and approximately 1,000 tumor organoid models powered by Hubrecht Organoid Technology, we offer unparalleled insights across 35 cancer indications. Our expertise spans in vivo, in vitro, ex vivo, and in silico methods, complemented by advanced laboratory services that span the entire drug development continuum. Additionally, our extensive biobank of liquid and human biospecimens, complete with clinical histories, enhances oncology research capabilities. Operating from 11 state-of-the-art facilities across the US, Europe, and APAC, our laboratories meet the highest industry standards, including accreditation by the College of American Pathologists (CAP) and the International Organization for Standardization (ISO). To learn more, visit www.crownbio.com.
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