BARDA and Visby Medical, Inc. of San Jose, California, will work together to develop an influenza and COVID-19 test for rapid detection of influenza A and influenza B as well as SARS-CoV-2.
Under a BARDA contract award, Visby will expand the company’s SARS-COV-2 test, which achieved emergency use authorization (EUA) to include a multiplexed Flu A and Flu B respiratory test with the goal of emergency use authorization (EUA) and, ultimately, 510(k) clearance.
The Visby Personal PCR test is being developed to help diagnose and distinguish rapidly between cases of influenza A, influenza B and SARS-CoV-2 viral infections from a single nasal swab sample, facilitating decisions about appropriate patient care and management including quarantine, as necessary.
The hand-held disposable device platform is expected to provide a sample-to-result time of less than 30 minutes. The test requires no additional equipment and is designed for both point-of-care (POC) and over-the-counter (OTC) use at home, avoiding lengthy delays caused by sample transport, laboratory analysis, and result reporting.
The potential OTC availability would greatly assist in minimizing patient exposure in POC settings and avoid the further spread of contagious viral infections in the current and potentially future pandemics to help save lives.
The Visby SARS-COV-2 test was developed with support from the National Institute of Biomedical Imaging and Bioengineering’s RADx program, part of the National Institutes of Health. That test recently achieved Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration.
About Visby Medical™
The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.
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 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.