August 24, 2020—Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has received its Certificate of Accreditation for high complexity testing in the diagnostic immunology specialty from the Commission on Office Laboratory Accreditation (COLA) for its U.S. facility in Durham, North Carolina. This accreditation confirms that BioAgilytix’s laboratory quality system meets or exceeds the Clinical Laboratory Improvement Amendments (CLIA) federal standards and all relevant state regulatory requirements. All testing performed in the U.S. that yields results used to direct patient care falls under CLIA oversight.
BioAgilytix’s Durham facility, which serves as the company’s U.S. headquarters, received its Certificate of Registration from CLIA last fall for high complexity testing in the diagnostic immunology specialty. At that time, it applied to pursue a Certificate of Accreditation with COLA and has since been surveyed by the agency and found to be in compliance with both CLIA and COLA standards for high complexity testing. CLIA requirements for this type of testing are most stringent and require both testing personnel and management to have advanced training and specialty expertise.
“To successfully receive a Certificate of Accreditation, you must demonstrate that your lab goes above and beyond the basic elements of CLIA compliance to meet expectations of an advanced quality system,” said Natalie Smith, BioAgilytix’s CLIA Laboratory Director. “It was important for us to pursue accreditation because we wanted to instill trust in our customers that any testing performed in our lab will be done in line with the most comprehensive laboratory standards and therefore stand up to strict regulatory scrutiny.”
As part of accreditation, the performance of the lab will be monitored by COLA on a continual basis. BioAgilytix’s CLIA-certified, COLA-accredited Durham laboratory now joins its CLIA-certified, CAP-accredited lab in Boston, MA to offer sponsors high-quality testing services found to adhere to established CLIA regulations, including those for reporting of patient-specific results.
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area, the Cambridge area of Massachusetts, and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e. product release testing, stability testing, etc.). BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory.
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to many of the top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.