Metabolon now offers more than 150 qualified and/or validated targeted biochemical assays for pharmaceutical and biotechnology R&D. 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. Developed biomarker assays reflect the evolution of global metabolomics and are excellent tools to rapidly and accurately establish pharmacodynamics and monitor efficacy and safety in clinical trials. The role of biomarkers is also expanding to inform new therapeutic indications and disease targets, patient segmentation and novel mechanisms of action
“Metabolomics is becoming a staple in studies of individual health, disease and treatment response,” said Mike Milburn, PhD, Chief Scientific Officer at Metabolon. “The biomarkers that emerge from ongoing research will ultimately produce tests that improve clinical trial assessment, disease management and patient care. Metabolon is pleased to announce expanded targeted assay solutions to support pharmaceutical and biotechnology partners in their mission to develop safe, effective medicines. We have a diverse selection of internally developed assays, as well as the ability to develop custom assays to meet research and clinical trial needs.”
Pharmaceutical and biotechnology researchers increasingly encounter metabolite biomarkers related to target biology or therapeutic effect and seek to use these findings to guide the drug development process.
“We recognize that increasing constraints on resources are pushing researchers to seek reliable partners to conduct biomarker assays for clinical trials,” continued Milburn. “We’re meeting that need based on a deep understanding of the clinical relevance of metabolites as biomarkers in disease and treatment, technology advances, and the limitations of legacy methods used in metabolite analysis, such as ELISA or IHC. Our technology and expertise can have significant, positive impact throughout the clinical development process.”
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’s pre-developed targeted assays 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
Metabolomics is the study of small molecules called metabolites and is a powerful phenotyping technology for life sciences research, population health and precision medicine. It measures changes in metabolite levels and maps them to the appropriate biochemical pathways to give researchers and clinicians a better understanding of health and the influences of genes, microbiome, diet, lifestyle, and drug treatment.