Avance Biosciences™ Registers with CLIA, Expanding Clinical Trial Testing Capabilities

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HOUSTON, Feb. 26, 2025 /PRNewswire/ — Avance Biosciences, a leading provider of high-quality analytical and bioanalytical services for the pharmaceutical industry, is pleased to announce that it has successfully registered with the Clinical Laboratory Improvement Amendments (CLIA) program. This registration allows Avance Biosciences 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.

“CLIA registration represents a major step in expanding clinical trial support.”

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 ensures 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 specialized assays to support clinical trials, biomarker development and validation, and diagnostic device development and validation.

“CLIA registration represents a significant step forward for Avance Biosciences as we continue to expand our support for clinical trials and biopharmaceutical development,” said Xuening Huang, CEO of Avance Biosciences. ” Industry experts who have reviewed our facility have described it as one of the most well-prepared CLIA labs they have encountered, reinforcing Avance’s commitment to excellence in providing high-quality, regulatory-compliant testing solutions that accelerate drug development and bring innovative therapies to patients faster.”

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.

About Avance Biosciences

Avance Biosciences is a leading provider of GLP/GMP-compliant analytical services supporting the development of biological drugs and companion diagnostics. Specializing in genomic, proteomic, immunoassay, and cell-based assay solutions, the company serves biopharmaceutical innovators with advanced testing capabilities tailored to regulatory requirements.

For more information about Avance Biosciences’ CLIA-certified testing services, please visit www.avancebio.com

Media Contact:

Chris Hebel
VP of Marketing
Avance Biosciences
chris.hebel@avancebio.com
281-799-3283

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SOURCE Avance Biosciences, Inc.

Staff

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