Assay development & validation

BiomarkerBay unique capabilities in

  • Fit-For-Purpose Biomarker validation from research setting to full GLP-compliant
  • High flexibility for biomarker analysis, with high resolution LC-MS/MS, Ligand binding assays, own developed assays or commercially available

At BiomarkerBay, internationally accepted guidelines are followed for the fit-for-purpose validation of the biomarker assay development, carefully selected to fit with its intended use. 

BiomarkerBay provides services for biomarker assay validation at these degrees: 

  • Research setting
  • Patient care (ISO 15189)
  • Implemented, qualified, validated (in the spirit of GLP),
  • Full GLP-compliant
  • Diagnostics (ISO 13485:2016)

The specifications of the biomarker assay,

Our biomarker assay experience on the type of biomarker, the matrix and the technique used for biomarker analysis include:

  • Type of biomarker: small molecules, metabolites, lipids, proteins, peptides, DNA, RNA, miRNA, metal and non metal elements;
  • Type of matrices: whole blood, plasma, serum, urine, faeces, cells, tissues, cerebral spinal fluid;
  • Methodology: genomics, proteomics technologies or imaging technologies, ligand binding assays, ELISA, LC-MS/MS, antibody production.

For an overview of established assays, please check our page biomarker assays.