Commercializing Novel IVDs:
A Comprehensive Manual for Success

Does your company have an idea for a novel biomarker test, but you’re unsure what the market potential will be? Have you invented a more sensitive test to diagnose a common autoimmune disorder, and but are unsure of what regulatory pathway to pursue? The process of developing a successful in vitro diagnostic (IVD) relies on the expertise of a diverse group of individuals, including the scientists who identify the biomarkers of significance, engineers and assay developers who translate those ideas into a tangible product, and the sales and marketing staff who will get your product into the market.

With a topic as complex as IVD development and commercialization, it became obvious that there was a real need within the industry to have a source that could serve as a reference guide. This unique manual will provide an overview of the major components to IVD development, from product conception through commercialization, and important considerations about individual aspects of the process.

commercialization of novel ivds highlights for success in diagnostics