GREENSBORO, NC – February 7, 2022 – Qorvo® (Nasdaq:QRVO), a leading provider of innovative RF solutions that connect the world, announced it has been awarded a $4.1 million follow-on contract with the National Institutes of Health (NIH) through the Rapid Acceleration of Diagnostics (RADxSM) initiative. The contract, awarded to Qorvo Biotechnologies, a wholly owned subsidiary of Qorvo, will help advance the clinical trials and market launch of both a SARS-CoV-2/ Flu Combo Assay and SARS-CoV-2 Antigen Pooling on the Qorvo Omnia™ diagnostic test platform.
The SARS-CoV-2/Flu Combo Assay will simultaneously detect and differentiate between SARS-CoV-2, Flu A and Flu B in an all-in-one test using a single swab sample in approximately 20 minutes. The antigen pooling application will allow up to six samples to be processed together and tested at the same time. Antigen pooling enables significant time and cost savings for screening groups of people who aren't experiencing SARS-CoV-2 symptoms. Qorvo continues to develop advanced testing formats for SARS-CoV-2 detection in response to the pandemic while focusing on test performance, workflow efficiencies and cost control for end users. Combined with a previous NIH contract award of $24.4 million, this award positions Qorvo to accelerate the production and market launch of multiple COVID testing solutions using a single platform.
Philip Chesley, president of Qorvo Biotechnologies, said, "Today's COVID testing market is demanding high quality testing infrastructure at the point of care (POC), with automated workflow, menu expansion and scalability to serve future needs of the pandemic. This contract award and continued RADx support enable Qorvo to more effectively address the expanding requirements of diverse end use settings."
Tiffani Bailey Lash, Ph.D., Co-Program Lead for the RADx Tech program, said, "Qorvo's antigen test has a lot of potential with near-PCR-level accuracy for use at POC settings."
The Qorvo Omnia platform represents an innovative 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.
This project has been funded in whole or in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No 75N92021C00008.
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.
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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