Empowering Drug Development with CLIA Testing Services

At Avance Biosciences, we understand that high-quality laboratory data is the backbone of successful drug development, especially when it comes to advancing biologics and companion diagnostics. With the rising complexity of clinical trials and the constant push for precision medicine, our CLIA-compliant testing services offer biopharmaceutical companies the regulatory assurance needed to drive drugs from the lab to real-world impact.

What is CLIA and Why Does It Matter for Drug Development?

The Clinical Laboratory Improvement Amendments (CLIA) program, regulated by the Centers for Medicare & Medicaid Services (CMS), sets strict standards for laboratory testing to ensure accuracy, reliability, and consistency. For biopharmaceutical companies, CLIA compliance is non-negotiable when test results are used for clinical decisions such as patient stratification, diagnostic development, or treatment strategies. Our CLIA testing services safeguard the integrity of your clinical trial data and provide the assurance needed to move forward with confidence.

Comprehensive CLIA Services for Every Stage of Drug Development

At Avance Biosciences, we’re committed to supporting the full spectrum of biological drug development, from preclinical research all the way to post-market monitoring. Whether you’re developing monoclonal antibodies, gene therapies, or cell-based treatments, our CLIA-compliant testing services ensure you meet the stringent regulatory requirements across various clinical phases.

Here’s how our CLIA services are shaping the future of drug development:

1. Biomarker Validation Biomarker testing is crucial for patient stratification, diagnostic development, and therapeutic monitoring. Our CLIA-certified labs perform cutting-edge biomarker analysis, empowering the development of targeted therapies tailored to patients who are most likely to benefit.

2. Pharmacogenomics Understanding how genetic variations affect drug responses is key to optimizing treatment protocols. We conduct comprehensive pharmacogenomic assays to help you identify the best drug dosages, reduce adverse effects, and ensure safer, more effective clinical trials.

3. Immunogenicity Testing To ensure the safety and efficacy of biologic drugs, it’s vital to understand the immune response. Our immunogenicity testing services include detection of anti-drug antibodies (ADAs) and comprehensive assays to evaluate immune responses that could impact both drug efficacy and patient safety.

4. Companion Diagnostics Development Our team collaborates closely with yours to develop and validate companion diagnostics, ensuring that the right patients receive the right treatment. By supporting personalized medicine strategies, we help enhance the efficacy of your biologic drugs.

5. Long-Term Follow-Up (LTFU) Ongoing monitoring is essential for ensuring patient safety and evaluating therapeutic efficacy over time. Our LTFU services provide long-term support for biologics, gene therapies, and advanced treatments, helping you identify adverse events and refine treatment protocols to enhance patient care.

6. Custom Assay Development Every drug development program is unique. That’s why we offer custom assay development services. Our scientific experts work alongside your team to develop and validate assays that meet the specific needs of your clinical trials and ensure the highest standards of accuracy.

Regulatory Support for Successful Submissions

Navigating the regulatory landscape can be challenging, but with Avance Biosciences by your side, you can be confident that our CLIA-compliant data will meet the rigorous standards of the FDA and global regulatory agencies. Our testing services are fully integrated with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), ensuring that your data is ready for regulatory submission.

Cutting-Edge Technology and Expertise

Backed by over a decade of expertise in biologics testing, we leverage advanced platforms like flow cytometry, PCR, MSD, NGS, qPCR/ddPCR, and ELISA to perform sophisticated assays. Our state-of-the-art laboratories, equipped with automated systems, enable high-throughput sample processing, providing you with efficient results without compromising quality.

Partnering for Your Success

As a trusted partner in drug development, Avance Biosciences is here to support you every step of the way. From regulatory submission to final commercialization, our CLIA-compliant testing services give you the confidence to move forward with your clinical trials and bring your innovative treatments to market.

Ready to learn more about how Avance Biosciences’ CLIA services can elevate your drug development program? Contact us today!