Delivering Clinical Insights with Targeted Biomarker Assays
Metabolomics reveals biological insights otherwise unseen, making it a crucial component of drug development. For a successful metabolomics study, both small molecule discovery and the ability to dig deeper into specific biomarkers of interest are needed to uncover actionable insights that propel new therapeutic developments. A specific combination of technology and expertise is required to identify these biomarkers of interest and develop assays that are sensitive enough to explore them fully.
At Metabolon, we understand the crucial role targeted small molecule assays play in drug development, and we’ve established best-in-class expertise. Metabolon has developed quantitative assays for more than 900 biochemicals in over 20 different matrices, including more than 150 qualified and/or validated targeted biochemical assays for pharmaceutical and biotechnology research and development. These assays focus on specific metabolites or metabolic pathways and can be used to track biomarkers and enhance biological understanding across preclinical and clinical research.
Our approach speaks directly to the questions biopharma research directors are seeking to answer, such as understanding their therapeutic’s mechanism of action, establishing pharmacodynamics, gauging safety and efficacy, defining patient segmentation, and conducting post-market surveillance. Once the critical biomarkers that are most important to researchers are identified through discovery, a more precise and accurate quantitation of the biomarkers is sought. Metabolon's strategic services offer biopharma clients global discovery followed with a direct targeted approach to dig deeper into promising and relvant biomarkers.
Metabolon’s targeted assay program is uniquely situated to fit into this workflow.
Targeted biomarker assay development is a natural progression following discovery using Metabolon’s first-in-class metabolomics platform. Metabolon’s discovery platform uses statistical approaches to assess the relative quantity of thousands of biomarkers. Our targeted assay program picks up from there, taking the discovery work and developing a more precise, accurate measurement of those few molecules that are of most interest. We apply LC-MS/MS based methods to determine absolute quantities of important biomarkers, using labeled internal standards as well as calibrators.
Our expertise in the measurement of endogenous biomarkers is unique and second to none. Most bioanalytical services offer expertise in exogenous biomarker measurements, such as the drug of interest or compounds that are exogenously introduced into a system. Metabolon targeted assays measure endogenous biomarkers naturally found at various levels within biological systems. Since endogenous biomarkers are sometimes present at the lower limits of analytical detection, the sensitivity of the assay becomes paramount. Furthermore, modest changes in biomarker levels may have biological relevance; Metabolon’s highly accurate targeted assays are required to tease out even modest changes in analyte levels. Our team of Ph.D. level method development scientists have a degree of experience in endogenous biomarker assay development that few places, if any, in the world can match. Our scientists are highly efficient and experienced in endogenous small molecule analysis, bringing additional data and actionable insights to drug development and clinical trials. No other bioanalytical company can translate metabolomic data and biomarker discovery into valuable biological insight using targeted LC-MS/MS analysis in the way that we can.
Finally, Metabolon’s capability is unique because we can operate under a research or clinical setting. In addition to our targeted work meeting specific client study demands, we also develop assays specifically used in clinical testing. Some of the pre-developed targeted assays offered by Metabolon include:
- Fatty acid metabolism panel
- Short-chain fatty acid panel
- Bile acid panel
- Cholesterol metabolism panel
- Stratum corneum panel
- Sebum lipid panel
- accuGFR™ panel (to estimate glomerular filtration rate)
- 7 alpha-hydroxy-4-cholesten-3-one (C4) panel
- Metal ion panel
LC-MS/MS-based assays can be customized based on client needs and developed under the quality system for research use only (RUO) or validated under Good Clinical Practice (GCP) and Clinical Laboratory Improvement Amendments (CLIA). Metabolon is ISO 9001: 2015 certified for analytical and diagnostic testing of biological specimens and accredited by the College of American Pathologists for diagnostic testing on human specimens.
Nowhere else will you find a laboratory like Metabolon’s that combines a world-class metabolomics discovery platform with a highly sophisticated analytical chemistry laboratory doing targeted analysis the way we do it. We have spent nearly 20 years building the best metabolomics competency in world to enable, accelerate and support drug development through biomarker discovery, understanding mechanism of action, patient stratification and more.
We proudly cover the whole breadth of the biopharma pipeline, from discovery to targeted analysis to clinical trial support, because your success is our goal.
Is your study yielding all the insights it could be? Download our free infographic to learn more about the five risks of drug development and how you can avoid them with metabolomics, and contact us today at email@example.com to get started.