Biomarker assays are laboratory methods that detect or analyze genes, proteins, or other molecules in a patient’s biological sample (tissue, blood, or other fluid). Biomarker assays are fundamental tests in biotherapeutic drug monitoring, research, and development, as they directly assess the presence of a disease state or biological characteristic of interest.
Prolytix offers comprehensive coagulation assays and the ability to run the entire catalog of Meso Scale Discovery (MSD) biomarker assays off the shelf. Additionally, our team has extensive experience in the development, validation, and execution of custom biomarker assays.
Biomarker Testing Services
Whether you are developing a protein-based therapeutic or other large-molecule drug product, all our biomarker tests are conducted from our GLP, GCLP, CLIA, and GMP bioanalytical facilities. Prolytix’s laboratories hold an outstanding FDA and client inspection track record, and our project management team puts customer success first with a 100% on-time delivery average. Our biomarker testing services include:
- Custom assay development and validation
- Commercial kit qualification/validation
- Transfer sponsor-specific proprietary assays for qualification of validation
- Thorough understanding of regulatory expectations for biomarker analytical validations based on the context of use
- Coagulation assays:
- Hemostatic risk assessment
- Platelet aggregation studies
- Thrombin generation assays (TGAs) and thromboelastograph (TEG)
- MSD biomarker assays
- Quantitative western blot
Biomarker Testing Technologies Utilized
- MSD-ECL Technology
- ELISA
- HPLC