BioAgilytix Receives CLIA Certificate of Registration
Regulatory Compliance

Have a Study that Requires Adherence to CLIA Regulations?

BioAgilytix Offers World-Class Bioanalytical Testing Services Under CLIA

How Does BioAgilytix’s CLIA Certification Make an Impact?

To better support our clients’ needs in obtaining patient-specific data that is necessary for making pivotal drug development decisions, BioAgilytix has invested in becoming certified by the Clinical Laboratory Improvement Amendments (CLIA) program.

This certification enables us to offer testing under CLIA at our U.S. facility in Durham, NC.

Bioanalytical Services Offered Under CLIA

CLIA Certification confirms BioAgilytix is able to perform lab-developed tests in the diagnostic immunology specialty that are deemed “high complexity” and subject to CLIA oversight.

As your trusted CRO partner, we are now able to provide you not only with data reported in aggregate for statistical analysis or batch results, but also with patient-specific results that could be used to affect the care or treatment of individual patients, including:

  • ADA, NAb, and Biomarker Assays for Clinical Trial Inclusion/Exclusion
  • PK/PD Testing to Guide Patient Dosing Strategies
  • Diagnostic Immunology

These services also help to support cell and gene therapy programs, as well as those for other personalized medicines. Tell us about your project needs today by completing the form.

To learn more about BioAgilytix’s CLIA Certificate of Registration and our available testing capabilities and expertise, read our press release below.

Read Press Release

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