SAN DIEGO — Crown Bioscience, a global contract research organization and a JSR Life Sciences company, said its San Diego laboratory has achieved accreditation from the College of American Pathologists, building on its Clinical Laboratory Improvement Amendments certification obtained in July 2025 and expanding its clinical-grade biomarker testing capabilities.
The CAP accreditation is widely regarded as a leading benchmark for laboratory quality, reflecting stringent standards for operational excellence, technical competence, and quality oversight. Combined with CLIA certification, which is regulated by the U.S. Centers for Medicare & Medicaid Services, the credentials confirm the 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 the addition of CAP accreditation, Crown Bioscience said its San Diego laboratory can more closely integrate biomarker testing across preclinical and clinical workflows, supporting continuity of data and regulatory alignment throughout drug development.
The milestone further strengthens Crown Bioscience’s global network of accredited and certified laboratories and reinforces its role as a partner to biotechnology and pharmaceutical companies advancing oncology and precision medicine programs.
