Biomarkers

Experienced in developing, qualifying and validating biomarker assays

Biomarkers

Frontage’s Bioanalytical Team is highly experienced in developing, qualifying and validating Biomarker assays. Our biomarker assay services provide accurate, reliable information. We can apply traditional and newer ELISA platforms as well as ultra-sensitive detection capabilities (Quanterix Simoa) for quantitation in the femtogram/mL range including single and multiplex analysis in various disease categories.

When biomarkers are present at extremely low levels in early stages of physiological abnormalities (i.e. well before the onset of disease symptoms) or when they are down regulated by therapeutic intervention, detection and quantification can enable early diagnosis and prediction of therapeutic effectiveness. However, too often traditional assay platforms cannot meet the required assay sensitivity needed. The sensitivity of the Quanterix Simoa analyzer makes it the instrument of choice for ultra-sensitive analysis of biomarkers.

Broad Range of Capabilities and Experience in Biomarker Assay Services

Our biomarker scientists have developed and validated a large number of biomarker assays for pharmaceutical and biotech companies. We are proud to become a benchmark in the field and have a significant impact for our clients using our expertise and state-of-the-art technology to advance/monitor drug development. We have also published novel biomarker assays developed in-house to share our expertise with the industry. With the addition of new technologies such as ELLA and Luminex for biomarker analysis, we believe we will continue as a top-notch provider of biomarker assay services in the years to come.

Biomarker areas of expertise include:

  • Fit-for-purpose (FFP) and Exploratory Biomarkers
  • Validation differences depending on the purpose of study and method categories
  • Method validation to support Labelling Claims, Safety, Efficacy
  • Significant endogenous levels of biomarker(s) of interest
  • Parameters of validation and level of “compliance” (fit-for purpose), methodology and SOPs
  • Define assay precision
  • Variety of platforms available (based on the endogenous biomarker amount in the matrix
  • Shared samples for many biomarkers
  • Complexity around analysis of “multiplex” data
  • Healthy vs Diseased performance differences
  • Potentially different locations, labs, companies, instrumentation,
  • Sample collection, processing and shipping inconsistencies
  • Matrix selection & volumes
Molecule Types Platforms Key Experiments Reagents
Cytokines LC-MS/MS, Method Development Commercially available assays
Proteins ICP-MS Validation Home brewed assays
Enzyme activity assays SimoaTM Precision/ Reproducibility
Small molecules Ella Parallelism
etc. Luminex Sensitivity/ Range
ELISA Stability and Sample Collection
MSD Specificity and interferences
Quality Controls (longitudinal and intra-run)

 

Therapeutically Focused Biomarkers

  • Oncology
  • Infectious Diseases 
  • Cardiovascular
  • Endocrine
  • Neurosciences
  • Inflammation
  • Respiratory