Visby Medical, San Jose, Calif, has received a $12.3 million award from Biomedical Advanced Research and Development Authority (BARDA) to speed development of its rapid, single-use Flu-Covid PCR Test. This agreement with BARDA—which is within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services—may be extended for a total of up to $48.7 million over a period of 38 months.
Visby Medical’s rapid RT-PCR assay to detect the novel coronavirus has received FDA emergency use authorization. This BARDA funding will advance a next-generation device to detect flu and/or covid-19 in one hand-held rapid PCR test for use at the point-of-need and eventually in consumer’s homes as an over-the-counter test. The goal is to provide frontline workers with rapid, accurate testing tools to fight the spread of covid-19.
“For decades we’ve known that delay in diagnosis can cost a patient and doctor precious treatment time. We knew we had to change the order to diagnose first, before treatment. It’s not enough to have a test; the test has to be right—and it has to be right now,” says Gary Schoolnik, MD, chief medical officer at Visby Medical and professor of medicine at Stanford University. “Visby Medical’s team brings a multidisciplinary approach, combining the expertise of leading scientists and doctors with engineers and product specialists to bring innovative technology to the diagnostic space.”
The Visby Medical Flu-COVID PCR Test will offer rapid PCR testing in a single-use, all-in-one device that fits in the palm of the hand. Designed for ease-of-use with no set-up time, and a fast sample-to-result time of less than 30 minutes, it is intended to detect and distinguish between influenza A and B and SARS-CoV-2.
“For too long, our medical professionals have been fighting blind without access to rapid, accurate diagnostic testing at the point-of-care, forcing physicians to treat patients before seeing the test result. The long-term cost to the patient, the doctor, and our community can be detrimental, including the increasing public health crisis of antibiotic resistance,” says Adam de la Zerda, PhD, founder and chief executive officer of Visby Medical. “The only way we can stop this is through rapid, and accurate diagnostics. Effective diagnosis at the point of care is the first step to both ending this pandemic and fighting the next. The good news is the investments being made into medical diagnostics should have a transformative effect long-term, and we are very pleased that BARDA recognized the importance of the Visby Medical platform technology in point-of-care and at-home settings.”
For more information, visit Visby Medical.