Visby Medical has secured additional funding of $25.5m from the US Biomedical Advanced Research and Development Authority (BARDA) to develop the Rapid Flu-COVID PCR Test designed for use at home.
The company has executed an option in a contract from last year, in which it initially received $12.3m funding from BARDA, to speed up its rapid, single-use Flu-COVID PCR Test development.
Currently in the development phase, the test has been designed as a handheld, all-in-one PCR device that can be used to detect and distinguish between SARS-CoV-2, influenza A and influenza B from a single sample.
With an expected accuracy rate that is similar to lab-based PCR tests, the Flu-COVID PCR Test provides results in about 30 minutes and does not require additional equipment.
The initial BARDA funding supported the obtaining of emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the use of the test in CLIA-waived point-of-care settings.
The new phase will support device development efforts and obtaining clearance from the FDA to offer the test to consumers directly through prescription.
This phase will also support the development of a digital companion system for interpreting test results and connecting patients with healthcare providers and public health reporting systems.
Visby Medical founder and CEO 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 minimise 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.”