Previously doing business as Click Diagnostics - an infectious disease diagnostic company - Visby Medical management describe themselves as in "stealth mode". Arguing that disease diagnoses should be quick, accurate, and readily accessible, the firm is structured around developing a device platform that would redefine the way ilness would be tested for - and treated. Click Diagnostics had been organized around the development of PCR-based diagnostic tests for the detection of sexually transmitted infections. The company also worked on a device platform with the defined objective of redefining the way an illness is tested and treated. Well backed financially, the premise is that by taking a human-centric, technology-first approach to device development, the firm can create tools that can be highly accurate and readily available. In February 2021, the firm was in receipt of a $12.3M grant from BARDA - Biomedical Advanced Research and Development Authority - located within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services (HHS) to work on development of a Rapid Flu-COVID PCR Test Designed for At-Home Use. This award is indicated as potentially scaleable to a total of $48.7M over a 3 year period. Also in February 2021 - under a new emergency authorization - the FDA gave full approval to Visby Medical's single-use, portable PCR test, The firm also successfully raised more than $250M in investment capital.
