We are honored to have been notified by the FDA of emergency use authorization (EUA) for application of our Personal PCR device to deliver reliable test results for COVID in under 30 minutes. The FDA has been working tirelessly throughout the pandemic to help bring new innovations to market in as safe a way possible, and we appreciate the dedication and cooperation of the FDA in helping us deliver Personal PCR for the fight against COVID-19.
Accessible, rapid, and reliable testing is imperative to returning society to a more open life. Many of the current testing solutions, however, sacrifice either speed for accuracy or accuracy for speed.
PCR, although widely recognized by the medical community as the gold standard in diagnostic accuracy, has limitations of capex investment, need for highly skilled resources, and long turnaround times resulting from bottlenecks in sample collection, sample transport, processing, and lab result reporting.
Personal PCR is a single-use device that is the size of a deck of cards. It is self-contained; no additional equipment is required. One device runs on one person’s sample and delivers the test result in less than 30 minutes.
We, Visby, have spent the past seven years developing Personal PCR. Incubated at Artiman Ventures in 2012, we are grateful for the support we received over the years from over 50 wonderful investors. We were also the beneficiary of several federal grants and awards that were instrumental to our success. Today, with moderate-complexity EUA, Visby’s Personal PCR will give labs the ability to deliver rapid PCR results for frontline healthcare workers, exposed employees, pre-surgical patients, and high-risk symptomatic patients.
Visby’s mid and long-term aspiration is to bring Personal PCR out of the lab environment into a point of care setting, and ultimately, in the hands of the consumer, to realize the ultimate vision of testing by anyone, anytime, anywhere. Creating COVID-Free Zones to help protect the most vulnerable of our community and enabling Day-0 Contact-Tracing will be the primary applications of our Personal PCR COVID test. More broadly, making PCR widely accessible would vastly increase our ability to respond not only to global pandemics — both today and in the future — but also to other common but dangerous infections.