Biomarker Expertise

Biomarkers play a crucial role in the era of precision medicine. The Biomarkers, EndpointS and other Tools (BEST) glossary explains a biomarker as a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers. Applications of biomarkers are being increasingly utilized in basic biomedical research and medical product development.

Founded in 2001, BSSI offers biomarker consulting and analytical services to the pharmaceutical and biotechnology industry. From the beginning, BSSI has been a pioneer in the field of translational sciences, specializing in biomarker analytics, and has become a preferred service provider of biomarker statistics for several major pharmaceutical companies.

Analytical support from discovery through clinical development and application:

  • Identification and validation of disease state biomarkers;
  • Measurement of pharmacokinetic (PK) markers to determine dosing;
  • Linking pharmacodynamic (PD) biomarkers to the mechanism of action (MOA) of a therapeutic intervention;
  • Analysis of predictive or prognostic biomarkers;
  • Utilization of biomarkers to identify and stratify patients with improved efficacy and safety profiles;
  • Assist the development and validation of diagnostic tools (e.g. companion diagnostics).

Experienced in analyzing different types of biomarker data:

  • Next generation sequencing (NGS) for DNA and RNA: whole genome or exome sequencing, RNA sequencing;
  • Microarrays for DNA and RNA: whole genome genotyping, candidate genes, methylation arrays, and gene expression arrays;
  • Immunoassays: enzyme-linked immunosorbent assay (ELISA) for proteins, and microsphere-based immuno-multiplexing for cytokines and chemokines, and others;
  • Imaging data, for example MRI and CT scans;
  • Data from other techniques such as immunohistochemistry (IHC), mass spectrometry, and flow cytometry.