Assay Development Services

With the rise of personalized medicine, drug developers are relying more on novel biomarkers from assay development companies to improve their success.

Assay development expertise

We have one of the most extensive routine and specialty testing menus in the industry and our technology partnerships and internal assay development programs have produced a large offering of novel biomarkers.  Since 2015, we have validated >450 new assays including over 250 biomarker assays each year.  

Our global laboratories, including 3 satellite translational science assay development laboratories, are equipped with industry-leading development expertise and value-added offerings. 

Our Translational Science Laboratories (TSL) focus on facilitating technology transfers from Sponsors, and developing and validating new assays with staff that are dedicated to assay development and validation. The TSL perform custom development and validation and re-validation of assays (fit-for-purpose or full extensive validation) and are committed to building strong and confident relationships between our scientists and customers.

We have recently collaborated with the University of Texas Medical Branch (UTMB) to develop a novel assay for COVID-19 (SARS-CoV-2) tests, to drive rapid development of a Coronavirus vaccine. Once a viable assay is developed, we will produce it for use in clinical trials to determine the effectiveness of a COVID-19 vaccine. Read more in our news release.

Meeting complex demands

Pharma and biotech companies are requesting increased complexity and shortened turnaround times for central laboratory services and testing requirements, including disease and drug-specific biomarker assessments and biomarker assay development to determine safety and efficacy for compounds in development.

As a global full-service laboratory provider with over 40 years of central laboratory experience, we are continually expanding capabilities to address growing demands by establishing specialized teams for assay development and testing, includes dedicated experts in bioanalytical and ADME, flow cytometry, genomics/bioinformatics, and companion diagnostics. Each of our central labs is staffed by dedicated teams of scientists and fully equipped with state-of-the-art technologies and standardized instrumentation. R&D (research and development) support includes expertise in fluid, tissue and cell-based assay development for biomarker testing, as well as a range of methodologies to address any specific biomarker and assay development demands of a study. 

Learn more about our biomarker capabilities.

For oncology drug development, our anatomic and molecular pathology, immunoassay and genomics-based assay development and testing, in conjunction with flow cytometry services provide a customized, end-to-end solution specifically suited for the unique combination of therapeutic indication and targeted mechanism-of-action.

Biomarker discovery and insights

Our biomarker discovery experts provide a better understanding of therapeutic targets, molecular signaling, drug biology and patient response. These insights can enable us to develop new assays for your trials.

Learn more about our central labs capabilities including our companion diagnostic and specimen management services.
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