Targeted Assays

Targeted assays are a valuable tool for rapidly and accurately establishing pharmacodynamics, translational studies, gauging efficacy and safety, and post-market surveillance studies. With several different sample matrices supported, deeper insights can be gained in various applications including microbiome research and bioprocessing.

From discovery to commercialization, improve biological understanding by tracking biomarkers with targeted metabolite assays. The role of biomarkers is expanding to inform new indications and targets, patient segmentation and novel mechanisms of action. According to the context of use of your biomarkers, Metabolon can guide you to ensure study integrity and high quality data generation in compliance with regulatory standards.

If one of our existing targeted assay panels doesn’t meet your needs, our experienced team of scientist can create a custom assay specifically for your area of interest. We have developed 150 customized assays representing >300 metabolites from all areas of the metabolome with multiplexing support. All of our assays are backed by our validations for Research use only (RUO) or GCP/GCLP and CLIA.

• Readily Available Quantitative Metabolite Assays or Custom Assay Development according to ISO 9001:2015 standards

• Fit-For-Purpose Biomarker Validation
• Capability to adhere to Good Clinical Practice (GCP)/ Good Clinical Laboratory Practice (GCLP) standards
• Extensive Method Validation according to FDA Bioanalytical Method Validation Guidance, 2018 or EMA Guideline on Bioanalytical Method Validation, 2011

• Capability to develop/validate methods and perform diagnostic testing on human samples according regulations certified by Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP) for diagnostic testing on human samples