For the well-being of your assay

Assay development

Assay development services

Assay Developmenting

Whether you are struggling with puzzling analysis results or you want to grow your new idea swiftly from scratch all the way to a marketed product, our assay development experts can help. Our dedicated assay development team will detangle all your R&D challenges with a proven high-quality approach that is compliant with ISO 13485.

“The ongoing collaboration with Kaivogen’s diagnostic assay development team has been very fruitful and enabled the maturation of our assay concept from its early drafts to a soon to be launched product.”

– Dag Christiansen, CEO, CardiNor

Our assay development workflow

You can pick only the desired functions from our assay development workflow, or we can grow your concept from the very beginning through all the steps to a finalized product (RUO or IVD). The extent of the project, preliminary timetable and budget as well as the needed level of documentation will be agreed upon prior to starting the project. A complete ISO 13485 compliant assay development project includes formal design reviews, documented procedures, result reports risk assessments throughout the entire project.

ELISA-assays, lanthanide-based immunoassays, nanoparticle-based assays and lateral flow applications – our flexible assay development process has helped various collaborators to achieve their assay development goals regardless of the detection method and assay configuration. We have a wide network of collaborators to enable, for example, the raising and production of antibodies and other proteins or instrument development.

Start your pathway to success with us!