Qorvo Biotechnologies Receives FDA Emergency Use Authorization (EUA) for Rapid COVID-19 Antigen Testing
April 15, 2021
Qorvo® (Nasdaq:QRVO), a leading provider of innovative radio frequency (RF) solutions that connect the world, today 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 (LOD) 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% 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.”
James Klein, President of Qorvo Biotechnologies, said, “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.”
For more information, visit www.qorvobiotech.com.
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.
Qorvo 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.
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