CLIA Testing Services
At Avance Biosciences, we understand the critical importance of high-quality laboratory data in supporting the development of biological drugs and companion diagnostics. 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.
Supporting Clinical Trials with CLIA
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. For biopharmaceutical companies, CLIA compliance is essential when laboratory test results inform clinical decisions, such as patient stratification, diagnostic, prognostic, or treatment strategy. Our CLIA labs ensure that every test is performed under the highest quality standards, safeguarding the integrity of your clinical trial data.
What We Offer
Our CLIA testing services support multiple stages of biological drug development, from preclinical research to clinical trials and post-market monitoring. Whether you’re developing monoclonal antibodies, gene therapies, or cell-based treatments, our team provides comprehensive testing solutions tailored to meet the regulatory demands of the biopharmaceutical industry.
CLIA Applications in Biological Drug Development
Application
Description
We perform biomarker testing to support patient stratification, diagnostic development, and therapeutic monitoring. Biomarkers are pivotal in precision medicine, allowing targeted therapies to be matched with the patients most likely to benefit.
We conduct pharmacogenomic assays that analyze how genetic variations influence drug response. This helps optimize treatment protocols by selecting the best drug dosages and minimizing adverse effects in clinical trial participants.
Understanding the immune response to biological drugs is critical. We perform comprehensive immunogenicity assays to detect anti-drug antibodies (ADAs) and evaluate potential immune responses that could impact drug efficacy or patient safety.
Our labs collaborate with your team to develop and validate companion diagnostics that identify patients for targeted treatments, ensuring the right therapy reaches the right patients. This supports personalized treatment strategies that enhance the efficacy of your biological drugs.
Our LTFU services are designed to monitor patient safety and therapeutic efficacy over extended periods following biologics, gene therapies, and other advanced treatments. This ongoing monitoring helps identify adverse events, improve treatment protocols, enhance patient care, and support regulatory compliance.
Our scientific experts collaborate with your team to develop and validate custom assays that meet the unique needs of your drug development program. From early discovery to late-phase clinical trials, we provide comprehensive support to ensure your assays meet the highest standards of accuracy and reliability.
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.
Unmatched Expertise and Cutting-Edge Technology
With over a decade of experience in biologics testing, our team at Avance Biosciences is dedicated to delivering precise, reliable, and timely test results. We leverage advanced molecular and immunological platforms, including flow cytometry, PCR, MSD, NGS, qPCR/ddPCR and ELISA to perform cutting-edge assays for drug and biomarker analysis. Our state-of-the-art laboratories are equipped with automated systems to support high-throughput sample processing, ensuring you receive results efficiently, without compromising quality.