Developing In Vitro Diagnostics for Commercialization and Clinical Implementation

For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/p5g92cb9/release/4 Even though in vitro diagnostics (IVDs) account for only 3% of healthcare spending, they generate results that drive 70% of healthcare decisions by providing vital insights into patient health. Development and implementation of IVDs should provide value not only within the diagnostic lab but also downstream in the clinical care pathway, by improving clinical outcomes and decreasing costs. This can be achieved by developing assays for new clinical biomarkers and/or with new analytical technologies that address unmet clinical needs. Academic entrepreneurs can either serve as technology inventors or subject matter experts and partner with major IVD companies to develop assays or platforms, or partner with startup companies to secure grants/venture capital funding to support the development, clinical validation, and regulatory approval of the inventions. Following regulatory approval, effective clinical implementation and adoption requires analytical performance and user experience suitable for clinical needs, reasonable placement of the technology within the clinical care pathway, effective user engagement and support, and positive health economics. There are opportunities for academics to engage and contribute to all of the above aspects.