Custom Biomarker Solutions for Every Stage of Development
Ligand Binding Assays & Multiplex Biomarker Detection
Our scientists leverage advanced ligand binding assay (LBA) platforms to develop customized biomarker assays tailored to your study. Using BioTek® Synergy™ microplate readers, we support absorbance, luminescence, and fluorescence applications. Our multiplexing expertise is powered by MSD® (including the S 600™ and QuickPlex® SQ 120) and the Luminex® 200™, enabling sensitive, high-throughput electrochemiluminescence and simultaneous detection of over 30 analytes. We also offer ELISpot and flow cytometry for single-cell biomarker analysis.
With over 30 state-of-the-art mass spectrometers, our LC-MS scientists provide high-resolution, accurate mass analysis for complex biomarker quantification. We apply hybrid extraction workflows and LC-MS detection to support protein biomarker determination with precision and speed, enhancing data quality across discovery and regulated studies.
Regulatory Guidance
The focus on biomarkers in aiding drug development is evident from the emphasis most regulators place on them due to their role in translational medicine. The FDA has a Biomarker Qualification Program for sponsors interested in developing biomarkers.
However, not all sponsors include biomarkers as a consideration early in the drug development process. Plan biomarker endpoints in preclinical studies to support efficacy and safety decisions later. This is the ideal time to determine which biomarkers can help establish efficacy and whether other biomarkers must be included to monitor safety as the drug progresses.
Biomarker bioanalysis is often harder than drug quantitation because many biomarkers are endogenous proteins. Work with a bioanalytical team that designs fit for purpose assays. Our toxicologists and clinical pharmacologists collaborate early to design a preclinical to clinical plan that improves data translation.
View our validated bioanalytical assay list and translational biomarker assays.
If you’re planning a study, review our biomarker assay list and contact us to discuss your requirements.