Avance Biosciences, a provider of analytical and bioanalytical services for the pharmaceutical industry, announced on Wednesday that it has registered with the Clinical Laboratory Improvement Amendments (CLIA) program.

This registration allows the company to operate under its assigned CLIA number and offer high-complexity laboratory testing to support clinical trials, regulatory submissions, and the development of companion diagnostics for biologic drugs.

By registering with CLIA, Avance Biosciences asserts that it has established the necessary infrastructure and quality systems to meet rigorous quality standards and federal regulatory requirements for laboratory testing. This commitment is intended to ensure the reliability and reproducibility of critical clinical trial data. Under this registration, the company now offers a comprehensive suite of biomarker validation, pharmacogenomics, immunogenicity testing, and other specialised assays to support clinical trials, biomarker development and validation, and diagnostic device development and validation.

With its CLIA registration, Avance Biosciences is positioned to support clients in the development of small molecule drugs and biologics, including mRNA therapeutics and vaccines, monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), as well as gene and cell therapeutics. By ensuring compliance with CLIA standards, the company provides the clinical data necessary for regulatory approvals while maintaining the highest levels of accuracy and consistency.