Visby Medical announced today that it picked up $25.5 million in government funding to develop an at-home flu/COVID-19 diagnostic.
San Jose, California-based Visby executed an option in a contract from the Biomedical Advanced Research and Development Authority (BARDA) on the additional $25.5 million for the development and validation of the at-home combination test. The incremental funding follows the initial contract, which was awarded in February 2021.
Visby said it designed its developmental-stage flu-COVID-19 PCR test as a single-use, handheld, all-in-one device for detecting and distinguishing between influenza A, influenza B and SARS-CoV-2 with a single sample. It delivers results in less than 30 minutes and requires no additional equipment.
“We are honored by BARDA’s confidence in our team’s ability to develop this test and bring it to market, and we’re excited to be a part of the solution to keep kids in school, businesses operational, and minimize the spread of infectious agents,” Visby Medical Founder and CEO Adam de la Zerda said in a news release. “Our mission has always been to help patients and healthcare providers test for any infection at any time in any location. Delivering this test to patients in their homes is just one more step towards achieving that goal.”
The first phase of the contract was to garner FDA emergency use authorization for use of the test in point-of-care settings, with the new phase supporting efforts to develop and obtain FDA clearance to offer the test directly to consumers via prescription. Additionally, Visby will develop a digital companion system for interpreting test results and connect patients, providers and public health reporting systems under the contract.
“Antiviral treatments are now available for COVID and both flu strains, but they are most effective when given early in the patient’s illness,” Visby Medical CMO Dr. Gary Schoolnik said in the release. “To achieve the best outcomes, patients and physicians don’t have the luxury of waiting several days for an accurate diagnosis, and this test solves that piece of the puzzle.”