GREENSBORO, NC – November 10, 2021 – Qorvo® (Nasdaq:QRVO), a leading provider of innovative RF solutions that connect the world, announced that two recent studies confirm that the Qorvo Omnia™ SARS-CoV-2 Antigen Test efficiently detected SARS-CoV-2 variants circulating in the United States. Of the two studies, one was conducted by Emory University, Georgia Institute of Technology, and Children’s Healthcare of Atlanta for the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative and the other was performed by the Qorvo Biotechnologies Research and Development laboratory in Plymouth, Minnesota.
As a RADxSM-supported company, Qorvo regularly validates the Omnia SARS-CoV-2 Antigen Test for new variant response in partnership with the RADxSM variant taskforce. Qorvo also performs internal testing on recombinant antigens with mutations specific to circulating variants. Recent work has focused on the Delta variant given significant national and international interest. Both datasets support the ability to detect all variants tested, and importantly, the Delta variant.
James Klein, President of Qorvo Biotechnologies, said, "These two studies of the SARS-CoV-2 variants demonstrate the robustness of the Qorvo Omnia SARS-CoV-2 Antigen Test in detecting circulating variants in the U.S. population. Accurate test results are critical to healthcare personnel as we continue the fight against this virus. Qorvo is pleased to play an active role in curbing the spread of SARS-CoV-2 in the U.S."
The Qorvo Omnia platform represents a novel diagnostic technique by using high frequency Bulk Acoustic Wave (BAW) sensors to achieve rapid SARS-CoV-2 (COVID-19) antigen test results. BAW sensor technology enables low limit of detection (LOD) levels similar to molecular testing capability.
For more information, visit www.qorvobiotech.com and download the Qorvo Biotechnologies Omnia™ SARS-CoV-2 Antigen Test Detects Delta and Other Circulating COVID-19 Variants White Paper.
This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. The current contract (75N92021C00008) 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 was granted emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) in April 2021. 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 having COVID-19 by their healthcare provider within the first 6 days of symptom onset.
The Qorvo Omnia SARS-CoV-2 Antigen Test has not been FDA cleared or approved. 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. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Qorvo Biotechnologies
Qorvo Biotechnologies, LLC is a wholly owned subsidiary of Qorvo, Inc. focused on the development of point-of-care (POC) diagnostics solutions leveraging Qorvo's innovative BAW sensor technology.
About Qorvo
Qorvo (Nasdaq: QRVO) makes a better world possible by providing innovative Radio Frequency (RF) solutions at the center of connectivity. We combine product and technology leadership, systems-level expertise and global manufacturing scale to quickly solve our customers' most complex technical challenges. Qorvo serves diverse high-growth segments of large global markets, including advanced wireless devices, wired and wireless networks and defense radar and communications. We also leverage unique competitive strengths to advance 5G networks, cloud computing, the Internet of Things, and other emerging applications that expand the global framework interconnecting people, places and things. Visit www.qorvo.com to learn how Qorvo connects the world.
Qorvo is a registered trademark of Qorvo, Inc. in the U.S. and in other countries. All other trademarks are the property of their respective owners.
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