A holistic pathway to biosensor translation

Abstract

Point-of-care (POC) biosensors have enormous potential to help guide and inform clinical decisions at a patient's location. They are particularly relevant to underserved populations, and people living in remote locations where healthcare infrastructure and resources are often limited. The translation of effective POC biosensors into commercial products is rapidly growing across many research fields. A significant quantity of scientific articles focused on the fundamental, applied, and proof-of-concept aspects of biosensing are reported each year. However, this extensive body of work is not reflected in the comparatively small number of commercial biosensors available on the market. Here, we discuss key aspects of the biosensor translation process including the selection of analytical biomarkers in various body fluids, clinical trials, regulatory approval, consumer engagement, manufacturing and scale-up strategies, health economics, and legal and ethical considerations.