Visby Medical Speeds Development of a Rapid Flu-COVID PCR Test Designed for At-Home Use with BARDA Funding

Visby Medical™ announced that it received a $12.3 million award to speed development of its rapid, single-use Flu-COVID PCR Test from Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, under contract 75A50121C00019. This agreement with BARDA may be extended for a total of up to $48.7 million over a period of 38 months. It is imperative that frontline workers in the US have rapid, accurate testing tools available to fight the spread of COVID-19 infection.

Founded by leading scientists in infectious diseases and diagnostics, Visby Medical has been working to change the order in which diagnosis and treatment of infectious disease occur. The FDA provided emergency use authorization for Visby Medical's rapid RT-PCR assay to detect the novel coronavirus. 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.  

"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," said Dr. Gary Schoolnik, Chief Medical Officer at Visby Medical and Professor of Medicine at Stanford University specializing in infectious diseases. "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 your 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. BARDA funding will help Visby Medical speed the development of its PCR Flu-COVID rapid test.

Adam de la Zerda, PhD, founder and Chief Executive Officer of Visby Medical, is motivated by a sense of duty — to patients and caregivers — to deliver rapid accurate testing results so doctors can make informed treatment decisions for patients with infectious diseases.

"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," de la Zerda said. "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."

About Visby Medical™:
Visby Medical has been working to change the order of diagnosis and treatment of infectious disease for a decade. Visby Medical has a single-use Personal PCR diagnostic to rapidly test for serious infection. Tested, reviewed, and endorsed by top public and private organizations, the first commercial application of the Visby Medical technology received FDA emergency use authorization for moderate-complexity laboratory testing of symptomatic patients in the fight against COVID-19. Visby is ramping production of its COVID-19 diagnostic test and is gaining government and private partnerships to accelerate the delivery of Personal PCR, designed for use at the point of care, and eventually for use at home.