Crown Bioscience San Diego Receives CLIA Certification to Expand Clinical Testing Capabilities
Key Insights
Crown Bioscience (search)'s San Diego laboratory has achieved Clinical Laboratory Improvement Amendments (CLIA) certification from the Centers for Medicare and Medicaid Services (search), enabling clinical-grade testing for drug development.
The certification allows the contract research organization to conduct clinical testing on human specimens, strengthening its position in oncology (search) research and personalized medicine.
Crown Bioscience (search) operates the world's largest commercially available patient-derived xenograft collection and approximately 1,000 tumor organoid models across 35 cancer (search) indications.
Crown Bioscience (search), a global contract research organization and part of JSR Life Sciences (search), announced that its San Diego laboratory has received Clinical Laboratory Improvement Amendments (CLIA) certification from the Centers for Medicare and Medicaid Services (search) (CMS). This milestone enables the company to deliver clinical-grade testing and strengthens its support for clients' clinical and translational drug development efforts.
CLIA certification sets rigorous federal standards for accuracy, reliability, and quality laboratory operations. With this designation, Crown Bioscience (search)'s San Diego facility affirms full compliance, providing clients with increased confidence in the biomarker data used for clinical decision-making and regulatory submissions.
Enhanced Clinical Testing Capabilities
"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 (search). "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 (search) is now equipped to conduct clinical testing on human specimens, a key component of advancing oncology (search) 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.
Comprehensive Oncology Research Platform
Crown Bioscience (search) operates as a global contract research organization dedicated to accelerating drug discovery and development in oncology (search) and immuno-oncology. The company partners with biotech and pharmaceutical companies to provide innovative, tailored solutions spanning preclinical research, translational platforms, and clinical trial support.
The organization maintains the world's largest commercially available patient-derived xenograft (PDX) collection and approximately 1,000 tumor organoid models powered by Hubrecht Organoid Technology, offering insights across 35 cancer (search) indications. Crown Bioscience (search)'s expertise spans in vivo, in vitro, ex vivo, and in silico methods, complemented by advanced laboratory services that span the entire drug development continuum.
Global Laboratory Network
The company operates from 11 state-of-the-art facilities across the United States, Europe, and Asia-Pacific region. Crown Bioscience (search)'s laboratories meet the highest industry standards, including accreditation by the College of American Pathologists (search) (CAP) and the International Organization for Standardization (search) (ISO).
Additionally, the organization maintains an extensive biobank of liquid and human biospecimens, complete with clinical histories, which enhances oncology (search) research capabilities for its pharmaceutical and biotechnology partners.