Leica Biosystems Newcastle Center for Enabling Precision Medicine Achieves CLIA Certification
The facility will begin developing antibody-drug-conjugates to enhance personalized cancer treatment.
NEWCASTLE UPON TYNE, January 16, 2025 – Leica Biosystems, a global leader in anatomic pathology, has received a Clinical Laboratory Improvement Amendments (CLIA) certification for its state-of-the-art research and development facility in Newcastle, United Kingdom. A CLIA certification means a facility has been certified by United States government regulators to test human specimens to diagnose, prevent or treat disease. Leica Biosystems has previously received CAP accreditation for its lab as well.
With this achievement validating the readiness and quality of the laboratory, Leica Biosystems will begin clinical trial testing and continue assay development with pharmaceutical partners to bring the promise of precision medicine closer to reality.
“Achieving CLIA status at our Newcastle laboratory gives us the capacity to expand our pharma partnership opportunities,” said Karan Arora, Senior Vice President of Advanced Assays and Pharma Services at Leica Biosystems. “The companion diagnostics we develop here will help physicians decide whether a patient will respond well to treatment, which can make a significant difference in patient outcomes.”
The news aligns to Leica Biosystems parent company Danaher’s recent announcement about a second CLIA laboratory in Carlsbad, California, where Leica Biosystems instrumentation will also be utilized.
About Leica Biosystems
Leica Biosystems is a cancer diagnostics company and a global leader in workflow solutions. The company offers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. As the only company to own the full workflow from biopsy to diagnosis, Leica Biosystems is uniquely positioned to break down the barriers between each step. The company’s mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of its corporate culture.
