Immunologix Laboratories Announces CLIA Certification

Immunologix Laboratories, a leading CRO in large-molecule bioanalytical testing, has received its Certificate of Registration from the Clinical Laboratory Improvement Amendments (CLIA) program. This registration allows Immunologix to not only fully support the bioanalytical needs of a clinical study but also to immediately support clinical testing that requires CLIA oversight. Such testing informs patient-specific decisions such as inclusion/exclusion for trial enrollment or changes in patient dosing by executing highly complex laboratory-developed testing (LDTs) for immunogenicity (e.g. ADA and NAb assays) and select biomarkers. Immunologix Labs is also pursuing accreditation from the Commission on Office Laboratory Accreditation (COLA) to further ensure our rigorous quality standards and commitment to scientific excellence.

Immunologix Chief Scientific Officer, Lauren Stevenson, says, “Our CLIA testing complements our suite of bioanalytical service offerings. We can now leverage our expertise in immunogenicity and quantitative analyses to further support drug development of our industry partners, particularly those navigating clinical trials for gene therapies. Gene therapy trials often require high complexity immunogenicity testing for patient selection. Whether for gene therapies or other large molecule modalities, we remain committed to delivering the highest quality data to facilitate the advancement of drugs to market.”