Biomarker method development & analysis (preclinical & clinical)

Record Type: Assay

Validation: GCP, GLP, Non-GLP

Models: Human, Mouse, Canine, NHP, Rat

Biomarker assay development and method validation is a complex process that depends on a number of parameters including choice of matrix, sample integrity, and assay standardization and accuracy.

Preclinical biomarker method development & analysis

Biomarker detection methodology for use on a preclinical study. Can develop assays for a variety of research models, utilizing numerous assay platforms as described below.

Clinical biomarker method development & analysis 

Multiple measurement modalities for semi-quantitative and qualitative analyses of multiple biomarkers in a variety of biological matrices. Performed on human samples.

Technology & platforms

  • Luminex: Fluorescent method for the quantification of multiple biomarkers in a variety of biological matrices. Allows for the quantification of the most biomarkers per sample of all biomarker detection methodologies.
  • MSD: Chemiluminescent method to quantify multiple biomarkers in a variety of biological matrices. Greatest dynamic range of all biomarker detection methodologies and greatest sensitivity.
  • ELISA: Colorimetric method to quantify individual biomarkers in a variety of biological matrices.

Also see biomarker development & validation during the discovery phase. 

Molecule or Product Type

Biomarkers

Industry Market

Pharma