Medical diagnostic company Visby Medical received $25.5 million in federal funding to develop and validate an at-home combination Flu-Covid test from the Biomedical Advanced Research and Development Authority (BARDA), funding which builds upon an earlier contract.
The developmental-stage Flu-COVID PCR Test is a single-use, handheld, all-in-one PCR device that detects and distinguishes between influenza A, influenza B, and SARS-CoV-2 from one sample, delivers results in less than 30 minutes, and requires no additional equipment. This incremental funding builds on the initial contract, announced Feb. 2, 2021.
The test offers a sample-to-result time of less than 30 minutes with an expected accuracy rate similar to lab-based PCR tests. In the first phase of the contract, BARDA-supported efforts to obtain FDA emergency use authorization for Visby’s rapid, single-use Flu-COVID PCR Test in CLIA-waived point of care settings. The new phase will support efforts to develop and obtain FDA clearance to offer the test directly to consumers via prescription; develop a digital companion system designed to interpret test results; and connect the patient with providers and public health reporting systems.
“Antiviral treatments are now available for COVID and both flu strains, but they are most effective when given early in the patient’s illness,” says Gary Schoolnik, MD, Visby Medical’s chief medical officer and professor of medicine at Stanford University specializing in infectious diseases. “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.”
In addition to implications for timely treatment, the availability of a highly accurate at-home diagnostic will allow consumers to test, talk to a clinician, and receive the proper treatment in a single visit, which may help reduce the risk of community spread.
“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,” says Adam de la Zerda, PhD, founder and chief executive officer of Visby Medical. “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.”
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority.