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Visby Medical Executes $25.5M BARDA Contract to Develop At-Home Flu, COVID-19 PCR Test

NEW YORK – Visby Medical announced on Friday that it will execute a $25.5 million contract option with the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop an at-home version of its handheld, PCR-based test for influenza and COVID-19.

The contract builds on initial BARDA funding of $12.3 million which supported the US Food and Drug Administration Emergency Use Authorization of a test for influenza A, influenza B, and SARS-CoV-2 for CLIA-waived point-of-care settings.

The at-home assay currently in development is a single-use, handheld, all-in-one PCR device that detects and distinguishes influenza A, influenza B, and SARS-CoV-2, delivering results in less than 30 minutes, Visby said in a statement.

The additional BARDA funding will now support efforts to further develop the test and obtain FDA clearance in order to offer it directly to consumers by prescription. The funding will also be used to develop a digital companion system designed to interpret test results and connect patients with providers and public health reporting systems.

Visby Chief Medical Officer Gary Schoolnik noted that new antiviral treatments for COVID-19 and flu are most effective when given early in an 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," he said.

Visby noted that a single-use device reduces the likelihood of PCR contamination and that testing at home can potentially reduce community spread.

Visby also obtained 510(k) clearance and CLIA waiver last year for a single-use, point-of-care assay to detect and distinguish the sexually-transmitted infections chlamydia, gonorrhea, and trichomoniasis.

In addition to BARDA, the firm's COVID testing efforts have been supported by $9.6 million from the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) program. The firm also raised $100 million in Series E financing this month to increase test production capacity.