Assay development & validation

Unique biomarker expertise

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

Assay development & validation

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)
Our experience for biomarker assay development includes:
  • 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, feces, cells, tissues, cerebral spinal fluid

The BiomarkerBay partners have provided biomarker analytical services to the pharmaceutical, biotech and diagnostic industries for more than 25 years. We rely on highly experienced bioanalytical and clinical experts with extensive background in assay development and high flexibility in working with a large variety of samples and technologies. 

For an overview of established assays, please check biomarker assay database.