Qorvo Biotechnologies granted emergency use authorization, awarded $24.4M contract, to produce COVID-19 rapid test

GREENSBORO — Qorvo Biotechnologies, a subsidiary of the publicly-traded, Greensboro-based Qorvo® has been awarded a $24.4 million contract with the United States National Institutes of Health (NIH) to advance the production and market launch of the Qorvo Omnia™ diagnostic test platform, which can be used to achieve rapid antigen testing to identify SARS-CoV-2 (COVID-19). Along with the contract, the company was granted emergency use authorization (EUA) by the United States Food and Drug Administration (FDA).

‘Widespread testing with rapid and reliable results plays a critical role in helping public health officials respond to infectious disease outbreaks,” said James Klein, president of Qorvo Biotechnologies. “We are committed to supporting the ongoing fight against COVID-19 as well as expanding the availability of tools with broader applicability.”

The company’s COVID-19 antigen test can deliver results in about 20 minutes, and uses high frequency bulk acoustic wave (BAW) sensors, enabling low limit of detection levels that are similar to molecular testing capability. Its design yielded 100 percent specificity during clinical trials, the company said in a statement.

“This is a big milestone for our company and our biotechnology subsidiary,” said Brent Diets, the director of corporate communications of Qorvo. “The team is excited about the opportunity and the additional funding that will allow them to continue their development efforts.”

The funding comes from the NIH Rapid Acceleration of Diagnostics (RADx℠) initiative, which launched in the early months of the global coronavirus pandemic to speed innovation in the research, development, and commercialization of technologies that would enable accurate COVID-19 testing.

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“Qorvo’s RF-based diagnostic technology has met review criteria to become a part of the RADx portfolio,” said Tiffani Bailey Lash, Ph.D., who co-leads the RADx initiative, in a statement. “Qorvo’s antigen test has a lot of potential with near-PCR-level accuracy for use at point-of-care settings.”

Part of the funding also includes federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. 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.

The Qorvo Omnia SARS-CoV-2 Antigen Test has not been FDA cleared or approved, the company noted.

It has been authorized by the FDA under an Emergency Use Authorization and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests.

The company’s test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The company employs about 1,400 full-time workers in North Carolina.