BiomarkerBay collaborates with biobanks, clinical experts and laboratories to help clinically validate your biomarker or companion diagnostic. Clinical validation is performed on good defined samples from a variety of biobanks. This includes large population cohorts, patient cohorts on specific diseases (Name the different ones) as well as the possibility to build new biobanks with sampling from both patients and healthy volunteers (see our biobank overview).
We offer support and consultancy services for the design and the execution of clinical studies to obtain IVD registration of (companion) diagnostics assays, in agreement with European directives and US regulation (also through notified body).
We provide tailored market searches and long-term assistance in the development and manufacturing of companion diagnostics kits under ISO 13485:2016.
We provide high quality services for clinical diagnostics, with specialty in antibody development and validation, protein expression and production of biomarkers.