The SARS-CoV-2 epidemic has shined a light on a major weakness of our healthcare system: the inability to quickly, accurately, and inexpensively screen large groups of individuals for infectious diseases. Such individuals could be community citizens, travelers at airports, attendees at large events, or even employees and patients at healthcare systems themselves. The traditional central laboratory testing model is laborious, expensive, and time-consuming. Results can take 1-3 days to return to the tested patient, which can render testing useless as nearby individuals will be needlessly exposed in the meantime. Furthermore, central laboratory testing in rural and low-income areas can be impossible due to the cost and requirements for electricity and infrastructure. A rapid and portable device will be required to properly conduct pathogen screening as more and more infectious diseases continue to emerge globally.
During the COVID outbreak, we saw the opportunity arise to impact public health not only in the USA, but worldwide. Within just a few years, we developed a flexible, scalable, low-cost screening platform based on cutting-edge technology licensed from Caltech. Our engineers joined ultra-high-tech cooling and heating elements with optical instrumentation to develop a system capable of running full PCR within ~15 minutes. Internal components of the device and consumable tests were sourced with scaled manufacturing in mind, and our manufacturing costs are projected to be lower than any competitive device. Initial laboratory testing at FastDetect headquarters has demonstrated >98% sensitivity and specificity for SARS-CoV-2 detection. This makes FastDetect the lowest-cost, highest-accuracy molecular diagnostics platform in the world, and it is ready to be deployed to fill this crucial market gap.