The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Qorvo’s QRVO Qorvo Omnia SARS-CoV-2 Antigen Test in Point-of-Care (POC) settings.
The antigen test is authorised for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 (COVID-19) in nasal swab specimens from individuals with suspected COVID-19 within six days of symptom onset.
The Qorvo Omnia test is also authorised for individuals without symptoms to suspect COVID-19 when tested twice over three days, with at least 24 hours and no more than 48 hours between tests.
Erik Allen, Vice president, commented: ”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 agency previously granted an emergency use authorization for use in moderate and high complexity settings such as laboratories.
Price Action : Qorvo shares are trading down around 3 percent at $103.99 on Thursday at the time of publication.