Qorvo® announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Qorvo Omnia™ SARS-CoV-2 Antigen Test. The test is authorized for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19.
The Qorvo Omnia platform represents a paradigm shift in diagnostic testing capability by using high frequency bulk acoustic wave (BAW) sensors to achieve SARS-CoV-2 (COVID-19) antigen testing in approximately 20 minutes. BAW sensor technology enables low limit of detection levels that are similar to molecular testing capability.
The Qorvo Omnia platform features a portable test instrument, microfluidic cartridge and secure connectivity. The microfluidic cartridge design enables specific binding with additional wash steps similar to central lab instrument operation and demonstrated results including 100 percent specificity during clinical trials.
Fred S. Apple, Ph.D., a member of Qorvo Biotechnologies’ advisory board, co-medical director of Toxicology Laboratory at Hennepin Healthcare/Hennepin County Medical Center and professor of Laboratory Medicine & Pathology at the University of Minnesota, said, “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.”
Qorvo has also been awarded a $24.4 million contract with the National Institutes of Health (NIH) through the Rapid Acceleration of Diagnostics (RADxSM) initiative. The contract helps advance the production and market launch of the Qorvo Omnia™ diagnostic test platform.
NIH launched RADx in the early months of the pandemic to speed innovation in the development and commercialization of technologies for COVID-19 testing. “Qorvo’s RF-based diagnostic technology has met review criteria to become a part of the RADx portfolio,” said Tiffani Bailey Lash, Ph.D., co-program Lead for the RADxTech program. “Qorvo’s antigen test has a lot of potential with near-PCR-level accuracy for use at point-of-care settings.”
James Klein, president of Qorvo Biotechnologies, said, “Widespread testing with rapid and reliable results plays a critical role in helping public health officials respond to infectious disease outbreaks. We are committed to supporting the ongoing fight against COVID-19 as well as expanding the availability of tools with broader applicability.”
This project has been funded in part by the NIH RADxSM initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, NIH. The current contract is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services.