Medical diagnostic company Visby Medical has executed $25.5m federal contract options with Biomedical Advanced Research and Development Authority (BARDA) to develop at-home Flu, Covid-19 PCR test.
The additional funding comes after the initial contract was signed in February last year.
The test, which is still in development, is a single-use, handheld, all-in-one PCR instrument that detects and identifies influenza A, influenza B, and SARS-CoV-2 from a single sample in less than 30 minutes without the need for any extra equipment.
California-based Visby designed the test for ease of use, low set-up time and a predicted accuracy rate comparable to lab-based PCR assays.
BARDA supported Visby in obtaining FDA emergency use authorisation for its test in CLIA-waived point-of-care settings during the first phase of the contract.
The latest phase will aim to gain FDA clearance for marketing the test directly to consumers via prescription. It also includes the development of a digital companion system for interpreting test results and connecting patients, providers and public health reporting systems.
Visby Medical chief medical officer Dr Gary Schoolnik said: “Antiviral treatments are now available for Covid and both flu strains, but they are most effective when given early in the patient’s illness.
“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.”
Additionally, the test will allow customers to test, consult with a doctor, and obtain the appropriate treatment all in one visit, potentially reducing the chance of community spread.
Visby Medical CEO and founder Adam de la Zerda said: “We are honoured 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.
“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.”
