The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Qorvo Omnia SARS-CoV-2 antigen test in point-of-care (POC) settings.
The test is authorized for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 (COVID-19) in nasal swab specimens from individuals who are suspected of COVID-19 within six days of symptom onset. The test is also authorized for individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days, with at least 24 hours and no more than 48 hours between tests. The FDA previously granted an EUA for use in moderate and high complexity settings such as laboratories. This EUA significantly expands the market for Qorvo beyond laboratories to include physician offices, urgent care centers, retail pharmacies, employee health testing and any other locations where CLIA waived tests can be performed.
Erik Allen, recently appointed vice president of Qorvo and president of Qorvo Biotechnologies, said, "As the COVID testing market transitions to an endemic state and the increase in the Omicron variant drives lower viral load, high quality rapid testing infrastructure is needed in POC settings. The Qorvo Omnia platform provides a unique combination of performance, automated workflow and scalability to serve on-site testing needs in a very efficient manner."
The Qorvo Omnia platform utilizes an innovative diagnostic technique by using high frequency Bulk Acoustic Wave (BAW) sensors to achieve highly sensitive and specific COVID-19 detection results with a fast turnaround time, in an easy to use, self-contained platform. BAW sensor technology enables low limit of detection (LOD) levels similar to molecular testing capability. As viral loads decrease particularly with the Omicron variant and sub-variants, low viral load in patient samples presents challenges for existing over-the-counter lateral flow antigen tests, giving the Qorvo Omnia platform a technological advantage to continue to accurately detect antigens associated with COVID-19 during Omicron surges.
The Omnia platform demonstrates excellent performance at the LOD for the comparator polymerase chain reaction (PCR) method. The Omnia platform demonstrated 85% sensitivity (PPA) during clinical studies to support the device EUA at the POC; this U.S. National Institutes of Health (NIH)-sponsored study took place in the latter part of 2021. A separate NIH-sponsored research study was conducted during Omicron variant circulation at the beginning of 2022. During this study, Qorvo continued to see exemplary performance at 86% sensitivity where samples were at or above the LOD of the comparator PCR method. In all studies, 100% specificity was observed.