CLIA Testing Services
We provide high-quality, CLIA-compliant testing to support the development of biological drugs and companion diagnostics.
Our services offer the regulatory assurance biopharma companies need to advance through clinical trials and into commercialization.
The Clinical Laboratory Improvement Amendments (CLIA) program, regulated by the Centers for Medicare & Medicaid Services (CMS), ensures that laboratories meet stringent standards for quality, reliability, and accuracy. Our CLIA-compliant testing services provide biopharmaceutical companies with the regulatory assurance needed to advance drug development through various phases of clinical trials and into commercialization.
Are You Prepared?
For biopharmaceutical companies, CLIA compliance is essential when laboratory test results inform clinical decisions, such as patient stratification, diagnostic, prognostic, or treatment strategy.
Our Expertise
- Biomarker Validation: Supporting precision medicine through diagnostic, stratification, and monitoring assays.
- Pharmacogenomics: Analyzing genetic variation to guide dosing and improve drug response.
- Immunogenicity Testing: Detecting anti-drug antibodies to evaluate immune response and drug safety.
- Companion Diagnostics: Developing assays to match patients with targeted therapies.
- Long-Term Follow-Up: Monitoring safety and efficacy of biologics and gene therapies over time.
- Custom Assay Development: Creating tailored assays to meet specific drug development needs.
Partnering for Regulatory Success
As your partner in drug development, Avance Biosciences provides regulatory submission support, ensuring that our CLIA data meet the requirements of the FDA and other global regulatory agencies. Our testing services are fully integrated with Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP), giving you the confidence to submit your data for regulatory approval.
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Our Customers Say…
Your team met the timelines we needed and did exceptional technical work. I will definitely make my management aware that Avance is a very capable partner for our bioanalytical needs.
Bioanalytical Senior Project Manager, California
Avance Biosciences™ (AB) has delivered the Sequencing data in a record time. Very impressive! We have benefited from AB’s hard work and are very grateful for that. AB team should feel proud of themselves. We thank AB team for their support and contributions, much appreciated.Head of Quality Control, Microbial Manufacturing Service, California
My experience with Avance has been nothing but positive… I will keep sending work your way as I appreciate the attention your team provides and Avance’s creative technical team. See you soon.Director Individualized Medicines, California
Avance has been the ideal partner in helping Mission Bio and our client,… be the first in the world to GMP qualify our single cell % transduction assay for a lentiviral gene therapy product. Excellent execution on the part of the Avance team. We look forward to more collaborations in the future.
Senior Director, Cell & Gene Therapy Business, California
From the preliminary conclusion of this work, we are already pleased to thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor…
Project Manager, Belgium
Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects.
Program Manager, California
It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences™’ services to colleagues and friends.
Senior Scientist, Singapore