Improve clinical trial outcomes with targeted metabolite assays
The Clinical Biomarker offering includes validated and custom-developed targeted assays for research and clinical use.
Metabolon’s unique approach, technology and experience across the biomarker development continuum make us a reliable partner for the development of known and novel metabolite assays and testing of clinical specimens within a quality system that meets regulatory needs.
All clinical biomarker sponsors receive a method validation report and data package resulting from testing their clinical specimens.
Validated Biomarker Assays
Metabolon offers validated biomarker assays in human plasma across many compound classes, including:
- Amino acids
- 25-Hydroxy vitamin D2 and 25-Hydroxy vitamin D3
Our menu of validated assays is constantly evolving to meet sponsor needs.
Clinical trial sponsors may also be interested in Quantose IR™ and Quantose IGT™, Metabolon’s proprietary panels for measuring insulin resistance and impaired glucose tolerance in fasted plasma.
Custom Biomarker Assays
Sponsors requiring custom assays or assays in other matrices not currently on the menu are invited to work with Metabolon scientists to create assays that meet their needs.
TrueMass biomarker assays are developed by a team of highly-qualified, Ph.D.-level bioanalytical chemists with extensive experience in assay development, validation and sample analysis. Custom biomarker projects vary based on the sponsor’s needs, but generally include:
- Affirmation of reference standards
- Development of pre-analytical and analytical methods
- Determination of recovery, stability, linearity and analytical measurement range (AMR)
- Assessment for multiplexability
- Validation of analytical performance
Qualified Biomarker Assays
Metabolon offers a library of over 150 qualified assays that can be readily validated. Please contact us for more information.