Qorvo® Biotechnologies Awarded $4.1 Million National Institutes of Health Contract for SARS-CoV-2/ Flu Combo and Antigen Pooling
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 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.
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions, and are not historical facts and typically are identified by use of terms such as "may," "will," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements included herein represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those expressed or implied by forward-looking statements. We do not intend to update any of these forward-looking statements or publicly announce the results of any revisions to these forward-looking statements, other than as is required under U.S. federal securities laws. Our business is subject to numerous risks and uncertainties, including those relating to fluctuations in our operating results; our substantial dependence on developing new products and achieving design wins; our dependence on several large customers for a substantial portion of our revenue; the COVID-19 pandemic materially and adversely affecting our financial condition and results of operations; a loss of revenue if defense and aerospace contracts are canceled or delayed; our dependence on third parties; risks related to sales through distributors; risks associated with the operation of our manufacturing facilities; business disruptions; poor manufacturing yields; increased inventory risks and costs due to timing of customer forecasts; our inability to effectively manage or maintain evolving relationships with platform providers; our ability to continue to innovate in a very competitive industry; underutilization of manufacturing facilities as a result of industry overcapacity; unfavorable changes in interest rates, pricing of certain precious metals, utility rates and foreign currency exchange rates; our acquisitions and other strategic investments failing to achieve financial or strategic objectives; our ability to attract, retain and motivate key employees; warranty claims, product recalls and product liability; changes in our effective tax rate; changes in the favorable tax status of certain of our subsidiaries; enactment of international or domestic tax legislation, or changes in regulatory guidance; risks associated with environmental, health and safety regulations and climate change; risks from international sales and operations; economic regulation in China; changes in government trade policies, including imposition of tariffs and export restrictions; we may not be able to generate sufficient cash to service all of our debt; restrictions imposed by the agreements governing our debt; our reliance on our intellectual property portfolio; claims of infringement of third-party intellectual property rights; security breaches and other similar disruptions compromising our information; theft, loss or misuse of personal data by or about our employees, customers or third parties; provisions in our governing documents and Delaware law may discourage takeovers and business combinations that our stockholders might consider to be in their best interests; and volatility in the price of our common stock. These and other risks and uncertainties, which are described in more detail in Qorvo's most recent Annual Report on Form 10-K and in other reports and statements filed with the Securities and Exchange Commission, could cause actual results and developments to be materially different from those expressed or implied by any of these forward-looking statements.
Qorvo BAW Technology
Learn how Qorvo Bulk Acoustic Wave (BAW) technology is revolutionizing the diagnostic testing landscape.
News and Events
Here you'll find the latest news and information from Qorvo Biotechnologies. Browse through our press releases, latest videos, upcoming events and related content.