FDA provides green signal to Qorvo's rapid COVID-19 antigen testing in POC

By Pranali Mehta  | Date: 2022-08-05

FDA provides green signal to Qorvo's rapid COVID-19 antigen testing in POC

Qorvo®, one of the significant connectivity and power solution providers globally, has recently declared that it has received the EUA (emergency use authorization) from the U.S. Food & Drug Administration (FDA) for its Qorvo Omnia™ COVID-19 Antigen Test in POC (Point-of-Care) settings.

The test has been sanctioned for the nucleocapsid viral antigens’ qualitative identification from SARS-CoV-2 (COVID-19) in nasal swab samples from people suspected of contracting the infection within six days of starting the symptoms.

Apparently, this test can also be performed on individuals showing no symptoms or other epidemiological causes to suspect COVID-19 when administered twice over the course of three days, with a minimum of 24 hours and a maximum of 48 hours passing between tests.

Earlier, the FDA had issued the EUA for use in moderate and highly complex contexts, such as laboratories.

For the uninitiated, this EUA assists Qorvo in significantly expanding its market from laboratories to physician offices, urgent care centers, employee health testing, retail pharmacies, and other locations where CLIA abandoned tests can be executed.

According to the recently appointed Vice President of Qorvo & President of Qorvo Biotechnologies, Erik Allen, the transition of the COVID testing market to an endemic state along with the rising omicron variant cases will drive the need for lower viral load, top-notch rapid testing infrastructure in the POC settings.

Erik added that the Qorvo Omnia platform offers a distinctive combination of automated workflow, scalability, and performance for assisting the on-site testing requirements in a very practical approach.

Peter Matos, President, and CEO of medical consultancy Traeokos, claimed that the antigen test by Qorvo will provide the level of performance required by the clients in several testing scenarios.

Peter also revealed that the testing needs have evolved considering the challenges presented by the Omicron variant.

 Previously, in April 2021, the Qorvo Omnia SARS-CoV-2 Antigen Test secured an EUA from the U.S. FDA for uses in mild and high complexity settings, and as of July 2022, it received EUA for the POC settings.

Source Credit - https://www.globenewswire.com/news-release/2022/08/04/2492301/11142/en/Qorvo-Biotechnologies-Receives-FDA-Emergency-Use-Authorization-EUA-for-Rapid-COVID-19-Antigen-Testing-at-the-Point-of-Care.html

About Author

Pranali Mehta     aeresearch.net

Pranali Mehta

A chemical engineer by qualification, Pranali Mehta has dutifully walked down the slated path and worked in the chemicals industry for a year. Her passion for writing however, pushed her into experimenting with the same as a career. With over three years of experience...

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