SAN DIEGO—October 30, 2025 — Crown Bioscience, a global contract research organization (CRO) headquartered in the United States and part of JSR Life Sciences and Japan-based JSR Corporation, today announced that its Suzhou, China laboratory has received Clinical Laboratory Improvement Amendments (CLIA) certification.
This achievement marks the company’s second CLIA certification in 2025, following its San Diego facility earlier this year, underscoring Crown Bioscience’s continued commitment to expanding its global network of compliant, clinical-grade laboratories.
Regulated by the Centers for Medicare and Medicaid Services (CMS), CLIA certification sets the highest federal standards for laboratory accuracy, reliability, and quality. The designation affirms that Crown Bioscience’s Suzhou laboratory meets all required compliance benchmarks, providing clients with greater confidence in the biomarker data that supports their clinical development and regulatory submissions.
"Earning a second CLIA certification within the same year reflects our global dedication to operational excellence and scientific integrity,” said Maria Radino, Vice President, Global Quality and Regulatory Compliance at Crown Bioscience. “With CLIA-certified laboratories in both the United States and China, we can now deliver consistent, regulated biomarker services across continents, accelerating translational research and advancing our clients’ therapeutic pipelines."
Building on its existing ISO 15189 accreditation, which demonstrates adherence to internationally recognized standards for medical laboratory quality and competence, this latest certification further strengthens Crown Bioscience’s regulatory portfolio. The Suzhou laboratory is now authorized to conduct clinical testing on human specimens, supporting oncology and immuno-oncology programs through high-quality biomarker analysis across its CLIA- and ISO 15189-accredited operations worldwide.
For more information about Crown Bioscience’s certifications and accreditations, please visit www.crownbio.com.
Media Inquiries:
Crown Bioscience
Sarah Martin-Tyrrell
pr@crownbio.com
