Qorvo this week said it received FDA emergency use authorization for its Omnia SARS-CoV-2 antigen test.
The diagnostic platform uses high-frequency bulk acoustic wave (BAW) sensors to test for COVID-19 antigens in approximately 20 minutes, according to the company. BAW sensors enable a low limit of detection levels that are similar to molecular testing capability.
“The FDA’s EUA is recognition that the Qorvo Omnia platform can help address the ongoing need for rapid, accurate and clinically-reliable diagnostic testing. We are honored to leverage Qorvo’s technology portfolio to help public health officials respond to this global pandemic,” president James Klein said.
Qorvo’s Omnia features a portable test instrument, a microfluidic cartridge with secure connectivity. The design of the microfluidic cartridge allows for specific binding with additional wash steps similar to central lab instrument operations with demonstrated results including 100% specificity during clinical trials.
“This is very exciting news. FDA authorization of Qorvo’s Omnia Antigen Test provides a rapid, sensitive and specific assessment of individuals, assisting providers trying to either rule in or rule out COVID-19, comparable to many of the PCR testing platforms in use. The testing system will hopefully be an avenue to assist in opening up the United States to be closer to business as usual,” Fred Apple, a member of Qorvo Biotechnologies’ advisory board, said in a news release.
The antigen test is not FDA cleared or approved. It has been authorized under an emergency use authorization with testing limited to laboratories certified under the Clinical Laboratory Amendments of 1988, 42 U.S.C. §263a, to perform moderate or high complexity tests.