The Bioanalytical Laboratory Can Now Perform Testing that is Subject to CLIA Oversight
OCTOBER 22, 2019—Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has received its Certificate of Registration from the Clinical Laboratory Improvement Amendments (CLIA) program regulated by the Centers for Medicare & Medicaid Services (CMS) for its U.S. facility in Durham, NC. Because CLIA requires a laboratory to perform on-site testing prior to being fully accredited, this certificate enables BioAgilytix to conduct nonwaived testing on human specimens for the purpose of health assessment or for the diagnosis, prevention, or treatment of disease until it is inspected by a CMS-approved accreditation agency to confirm its compliance with CLIA regulations. BioAgilytix is currently enrolled to be surveyed for accreditation by the Commission on Office Laboratory Accreditation (COLA) in the coming months.
The CLIA certificate confirms that BioAgilytix is now able to perform lab-developed tests in the diagnostic immunology specialty that are deemed “high complexity” and subject to CLIA oversight, such as ADA, NAb, and biomarker assays used to determine patient inclusion and exclusion criteria for trial enrollment. This also includes studies that involve reporting of patient-specific results that can or will be used to affect the care or treatment of a patient, such as data to gauge dosing for individuals among the standard dosing of a general study population.
“We are excited to now offer our customers bioanalytical testing services under CLIA, and give them the confidence that their clinical studies will follow all critical CLIA regulatory standards and requirements,” said Natalie Smith, BioAgilytix’s CLIA Laboratory Director. “This certificate gives us immediate capability to provide patient-specific data that will help our clients make pivotal decisions regarding drug safety, dosing, and inclusion/exclusion criteria for patient enrollment in clinical trials. Patient-specific reporting is particularly important when supporting gene therapy programs and the development of personalized medicines – both areas where many of our customers are putting more focus. We’re dedicated to ensuring our quality standard remains exceptional and continues to rise to meet the needs of our clients, and our CLIA certification is the latest example of that commitment.”
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area 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’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.