Planning to commercialize your biomarker invention?
Thousands of candidate biomarkers are being discovered and the number of publications has exploded in recent years, but the discovery of a candidate biomarker is just the beginning of a long road to a commercial product.
Few findings enter to the specific assay development phase, pass the evaluation of analytical and clinical performance characteristics, and are eventually transformed into IVD assays, as biomarker development and commercialization is complicated, time consuming and expensive.
To support and help the commercialization process of new in vitro diagnostics (IVD)-applicable biomarkers, a set of tools and useful information was made available free of charge. The tools give structure and validation to biomarker research. They guide researchers and product developers through the technology readiness levels and remind about the clinical, regulatory, and business aspects of the innovation process.
The tools are only intended as guidance. They have been compiled to the best of our knowledge from a wide variety of sources, but cannot claim to be complete. Each new discovery or development is individual, therefore all information and mentioned standards have to be considered for the concrete individual case. As soon as possible, think of establishing a dialogue with specialists and experts in the field.
The tools are intended for researchers, SMEs and technology transfer offices and are available to all free of charge.
Choose a tool to get started: