Biomarker Analysis & Validation

Advanced capabilities for molecular, proteomic and cellular analysis of biomarker signatures 

Biomarker evaluations have become an integral tool for enhanced diagnostic capability in the design and development of targeted therapeutics, adding tremendous potential value to pharmaceutical programs with far-reaching applicability. Through identification of druggable targets, characterization of indicators of disease severity or stratification of patient populations, biomarker analysis has advanced the field of precision medicine from a future possibility to present feasibility.

Our highly-experienced team of biomarker experts applies systematic, scientifically-rigorous approaches to the discovery and development of biomarker candidates to provide solutions to complex translational questions. With decades of combined experience through hundreds of studies across dozens of therapeutic areas, MD Biosciences can provide the services and expertise required to accelerate development of therapeutics. Our capabilities include support for projects at every stage in the development pipeline, from the initial biomarker identification, qualification and validation through to downstream clinical applications.

Whether a company is interested in the MOA of an early-stage preclinical candidate or evaluation of endpoint criteria in a late-stage clinical trial, our biomarker laboratory can provide researchers with highly relevant data in highly specific contexts to support data-driven decision making by our clients.

Our biomarker services are both platform and sample-agnostic, with technical capabilities including:

• Multi-parametric flow cytometry for evaluations such as immunophenotyping and population analysis (standard and custom panels) with BD LSR Fortessa 
• Cell-based in vitro assays and ex vivo analysis
• Molecular analytics via modern, highly-sensitive qPCR, microarray and NGS technologies
• Singleplex, multiplex and ELISA-based protein analysis
• Mutational and epigenetic analyses (B-RAF, K-RAS, EGFR, promotor methylation states)
• Fully-equipped GLP histology services including processing, histochemistry, and IHC
• Tissue sourcing and biobanking (fresh frozen, FFPE, liquid biopsy, disaggregated tumor cells, etc)
• Regulatory support and consultation
• Custom fit-for-purpose assay design, development and validation