The US Food and Drug Administration (FDA) has granted 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for Visby Medical’s polymerase chain reaction (PCR) test to detect respiratory infections.
The point-of-care Visby Medical Respiratory Health Test is claimed to be the first handheld test that can identify and distinguish between influenzas A and B, and SARS-CoV-2, the virus responsible for Covid-19.
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Visby Medical chief medical officer and Stanford University Medicine professor Dr Gary Schoolnik said: “This FDA decision ensures that accurate, rapid testing with the Visby Medical Respiratory Health Test will remain available to help physicians quickly diagnose and treat patients as they face upcoming respiratory seasons.
“Fast diagnosis of patients with respiratory symptoms — enabling selection of the most appropriate treatments — is increasingly important to the medical community.”
Offering results within 30 minutes, the test is tailored to improve patient care by enabling diagnoses at the point of care, particularly in remote and resource-limited settings.
Visby’s platform provides “true” PCR technology, which is said to be the gold standard for testing influenzas A and B, and Covid-19.
In December 2022, this multiplexed molecular test received emergency use authorisation from the FDA.
The company’s project received support in whole or in part with funding from the Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA), and the Administration for Strategic Preparedness and Response.
Ongoing BARDA-funded studies aim to expand the device’s capabilities, potentially paving the way for an at-home respiratory test.
Since its founding in 2012, Visby Medical has focused on streamlining the diagnosis and treatment process for infectious conditions.
In 2021, the company received a $12.3m award from BARDA to expedite the development of its rapid, single-use Flu-Covid PCR Test.
