The Biomedical Advanced Research and Development Authority (BARDA) and Visby Medical, Inc. of San Jose, California, will work together to develop a combination test for rapid detection of influenza A and influenza B as well as SARS-CoV-2, according to a February 2 announcement.
Under a BARDA contract award, Visby will expand the company’s SARS-COV-2 test, which achieved emergency use authorization (EUA) from the Food and Drug Administration, to include a multiplexed Flu A and Flu B respiratory test. The company's goal for the combined test is an 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 was awarded an EUA in September.