We are pleased to announce our Reno, Nevada facility recently received Clinical Laboratory Improvement Amendments (CLIA) certification. The CLIA regulations aim to ensure accuracy, reliability, and timeliness of patient test results and include federal standards applicable to all US facilities or sites that test human specimens to either provide a health assessment or diagnose, prevent, or treat disease. The addition of the CLIA certification provides even more versatility to support your diagnostic needs in drug development and helps make informed decisions faster from lead optimization to commercialization. “I am very proud of how quickly the Reno site obtained CLIA certification,” said Rob Stachlewitz, CVP of Global Lab Sciences. “We are excited to supply these services that are so much in demand and to be able to provide end-to-end diagnostic assay services to our clients for all phases of drug development, including post market.”
Clinical Laboratory Improvement Amendments (CLIA)
CLIA requires clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. This testing helps assess patient health to make clinical decisions for care.
The Laboratory Sciences group has world-renowned technical and scientific expertise with many diverse platforms to test samples from non-clinical and clinical studies to support biotherapeutic drug development programs (e.g., PCR, flow cytometry, bioanalysis, biomarkers, and immunogenicity) under GLP regulations, providing a solid foundation for offering testing under CLIA. We have the capability to quickly develop assays on many different platforms and analyze a high volume of samples using automation to support drug and biomarker development for early discovery through postmarketing patient safety monitoring.
The CLIA certification expands Charles River’s offering in analytical laboratory support for all phases of clinical trials. Clients now have access to:
- Diagnostic testing through commercial FDA approved and Laboratory Developed Tests (LDTs)
- Postmarket approved drug patient safety monitoring
- Immunogenicity and serology tests
- Therapeutic drug monitoring
- Companion diagnostics/precision medicine testing
“CLIA testing at Charles River is a significant step forward in our ability to provide end-to-end support for our customers and local communities,” said Vimal Patel, Reno’s Senior Director of Laboratory Sciences. “Leveraging our expertise in drug development provides a solid foundation in providing high quality results for diagnostic testing and adds to our mission of improving the quality of patients’ lives and delivering drugs to the market faster.”