Qorvo® detects Delta and other circulating variants in two studies

Qorvo® Biotechnologies Omnia™ SARS-CoV-2 Antigen Test Detects Delta and Other Circulating Variants in Two Studies

BEIJING, China, November 16, 2021 – Qorvo®, Inc., a leading provider of innovative RF solutions for mobile, infrastructure and aerospace & defense applications, announced that two recent studies have confirmed that the Qorvo Omnia™ SARS-CoV-2 Antigen Test effectively detects SARS-CoV-2 variants circulating in the U.S. One of the studies was conducted jointly by Emory University, Georgia Institute of Technology and Children’s Healthcare of Atlanta in response to the National Institutes of Health (NIH) Rapid Diagnostics Acceleration (RADxSM) program, and the other was conducted by Qorvo Biotechnologies’ R&D laboratory in Plymouth, Minnesota.

As a RADxSM-supported company, Qorvo works with the RADxSM Variant Working Group to regularly validate the Omnia SARS-CoV-2 Antigen Test's response to emerging variants. Qorvo also performs internal testing of recombinant antigens with mutations specific to spreading variants. Recent work has focused on the Delta variant, which is of great concern to the United States and the international community. Both datasets support the ability to detect all known variants, especially the Delta variant.

"These two studies on SARS-CoV-2 variants demonstrate the robustness of the Qorvo Omnia SARS-CoV-2 Antigen Test to detect circulating variants in the U.S. population," said James Klein, president of Qorvo Biotechnologies. "Accurate test results are critical to health care workers as we continue to fight this virus. Qorvo is pleased to play an active role in curbing the spread of SARS-CoV-2 in the U.S.."

Qorvo's Omnia platform is an innovative diagnostic technology that can rapidly obtain SARS-CoV-2 (COVID-19) antigen test results using high-frequency bulk acoustic wave (BAW) sensors. BAW sensor technology can achieve low limits of detection (LOD) levels that approximate molecular detection capabilities.

Omina™ SARS-CoV-2 Antigen Test Detects Delta and Other Circulating COVID-19 Variants” White Paper.

The project is funded in part by the NIH Rapid Diagnostics Acceleration (RADxSM) program, with federal funds from the National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health. The current contract (75N92021C00008) is funded by the Biomedical Advanced Research and Development Authority (BARDA) from the Public Health and Social Services Emergency Fund. The authority is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

In April 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Qorvo Omnia SARS-CoV-2 Antigen Test. The test is authorized for use by healthcare providers as a qualitative test to determine the presence of SARS-CoV-2 virus nucleocapsid antigens in nasal swab specimens from patients suspected of having COVID-19 within 6 days before symptom onset.

The Qorvo Omnia SARS-CoV-2 Antigen Test has not been cleared or approved by the FDA. It is authorized by the FDA under the Emergency Use Authorization regulations for moderate or high complexity testing only by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 USC § 263a. The tests are authorized only for the detection of proteins from SARS-CoV-2 and not for any other viruses or pathogens. These tests are authorized for use only for the period of time stated in the Emergency Use Authorization Act, section 564(b)(1), 21 USC § 360bbb-3(b)(1), for the detection and/or diagnosis of COVID-19, unless the authorization is terminated or revoked sooner.

About Qorvo

Qorvo has long been committed to providing innovative RF solutions to enable a better connected world. We combine product and technology leadership, system-level expertise and global manufacturing scale to quickly solve our customers' most complex technical challenges. Qorvo serves global markets, including advanced wireless devices, wired and wireless networks, and air defense radar and communication systems. We continue to maintain our leading edge in these high-growth areas. We also use our unique competitive advantages to advance 5G networks, cloud computing, the Internet of Things, and other emerging application markets to achieve the global connection of people, places and things.