Visby Medical Inc. secured $12.3 million in funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a next generation device to detect influenza and COVID-19 in a single point-of-care rapid PCR test and, subsequently, as an over-the-counter test for consumer use. The contract may be extended up to a total of $48.7 million over a period of 38 months based on meeting certain milestones in the base period, according to Visby Founder and CEO Adam de la Zerda.

Visby’s rapid RT-PCR assay to detect SARS-CoV-2 received emergency use authorization (EUA) from the U.S. FDA in September 2020. The disposable, hand-held device produces results in under 30 minutes from samples gathered by nasopharyngeal, nasal, or mid-turbinate swabs taken by a health care provider or patients suspected of having COVID-19 in a health care setting.

The first authorized rapid test using the gold standard of PCR technology for COVID-19 diagnosis, the system provides lab-quality sensitivity and specificity without the delays associated with sending out samples for laboratory processing. In some cases, the device could provide results days or even weeks faster than many areas have experienced during surges in the pandemic.

The BARDA award will enable San Jose, Calif.-based Visby to speed development of the integrated influenza/COVID-19 test. Like the COVID-19 test, the combined version will require users to collect a nasal sample, add the swab to the provided buffer, and input an aliquot of the sample into the device. Results are produced with half an hour of closing the input port and plugging in the device.

The test has two built-in controls to ensure the device is working properly. The displays a green LED check to indicate no issues with the functioning of the test in terms of temperature, flow, and other factors. In addition, “the in-process control amplifies a gene target that is always present in human samples. When this control spot is present, it demonstrates that the amplification and detection steps worked as intended,” de la Zerda told BioWorld.

Adding a multiplexed test for influenza A and influenza B will enable patients with the flu to start treatment with appropriate medications, such as Theraflu, in a timely way. At the same time, the combination will limit the need to quarantine individuals who have symptoms common to both infections when they only have the flu without overlooking cases of co-infection or failing to identify COVID-19 infections.

The device is expected to be on the market quickly. “For [point-of-care] use, we hope to launch as soon as possible, and will follow FDA requirements for authorization,” de la Zerda said. “The OTC version will follow as soon as the regulatory process allows.”

So far, the test picks up identified variants in SARS-CoV-2 that have raised concerns. In part, the assay has been unaffected because it does not focus on the S gene responsible for the spike protein, which has seen multiple significant changes in the variants of concern, but instead amplifies a region on the nucleocapsid gene. Visby continues to test its probes and primers to ensure they are not affected by new variants.

Speeding diagnoses

Providing tools to allow health care providers to quickly diagnose infections is Visby’s core mission. The pandemic has driven home the importance of this goal as delays in diagnosis have both driven up infection rates and resulted in unnecessary lost days of work for those uninfected.

For infectious diseases in general, delays in diagnosis are more the rule than the exception. “In the infectious disease space, empirical treatment is the norm, i.e., a patient is treated based on signs and symptoms, not based on a confirmed diagnostic test,” de la Zerda noted. “Part of the reason for empirical treatment is the long lead time to get test results back – this can take at least 24 hours and typically takes a few days. Doctors want to treat patients during the time frame of their visit to prevent patients being lost to care.”

Proceeding with a “best guess” can lead to both over- and undertreatment of disease and contributes to antimicrobial resistance. Tests that return rapid and accurate results during a visit could ensure patients receive the right treatment at the right time.

“The good news is the investments being made into medical diagnostics should have a transformative effect long-term, and we are very pleased that BARDA recognized the importance of the Visby Medical platform technology in point-of-care and at-home settings,” de la Zerda added.

This isn’t the first time the company has earned BARDA’s support. In August, BARDA and the National Institutes of Health awarded the company $19 million in the Antimicrobial Resistance Diagnostic Challenge for its diagnostic test that detects Neisseria gonorrhoeae and determines whether the organism is susceptible to a single-dose antibiotic. Treatment of gonorrhea has become limited to two drugs, one injectable and an oral antibiotic, the NIH said, highlighting the difficulty in treating the disease. Visby is developing several applications of its technology to diagnose sexually transmitted and other infectious diseases.