Celerion, a clinical research organization, announced its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) certification for its state-of-the-art bioanalytical laboratory located in Lincoln, Nebraska. This significant milestone marks a pivotal step in Celerion’s commitment to advancing healthcare by integrating high-complexity testing and diagnostic services into its comprehensive suite of bioanalytical solutions.
Celerion’s clinical laboratories, including their Lincoln site, have been CLIA-certified and CAP-accredited for over 25 years, which helped facilitate the CLIA certification of the laboratory. The CLIA certification is a testament to Celerion’s adherence to the highest standards of laboratory quality and competence. It enables Celerion to conduct non-waived testing on human specimens, a critical component in the health assessment, diagnosis, prevention, and treatment of diseases. This certification is particularly crucial as it allows Celerion to perform these vital tests prior to the full accreditation inspection by a CMS-approved agency, ensuring continuous advancement in patient care and clinical research.
With this certification, Celerion’s bioanalytical laboratory is now able to conduct lab-developed tests in specialized areas such as diagnostic immunology. These tests, recognized for their “high complexity” and stringent CLIA oversight, include but are not limited to ADA (anti-drug antibodies), NAb (neutralizing antibodies), and a wide array of biomarker assays. These assays are instrumental in determining patient inclusion and exclusion criteria for clinical trial enrollment, thereby enhancing the precision and efficacy of clinical studies. Moreover, the CLIA certification allows Celerion to engage in studies that require the reporting of patient-specific results. This capability is crucial for tailoring patient care and treatment, such as adjusting individual dosing based on specific data, distinct from the standard dosing for the general study population. This approach not only underscores the personalized aspect of patient care, but also significantly contributes to the optimization of therapeutic strategies and outcomes.
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