Qorvo® Biotechnologies Receives FDA Emergency Use Authorization (EUA) for Rapid COVID-19 Antigen Testing at the Point of Care

Rhea-AI Summary

Qorvo (Nasdaq: QRVO) announced the FDA's emergency use authorization (EUA) for its Qorvo Omnia™ SARS-CoV-2 Antigen Test, now available in Point-of-Care (POC) settings. This test allows qualitative detection of COVID-19 antigens in individuals suspected of infection, expanding market access to physician offices, pharmacies, and urgent care centers. The Omnia platform utilizes advanced Bulk Acoustic Wave (BAW) sensor technology, achieving high sensitivity and specificity rates of 85% and 86%, respectively, during clinical studies. This strategic move positions Qorvo favorably in the evolving testing landscape.

Positive

• FDA granted EUA for Qorvo Omnia SARS-CoV-2 Antigen Test in POC settings.
• The test expands market access beyond laboratories to various healthcare facilities.
• High sensitivity (85%-86%) and 100% specificity demonstrated in clinical studies.
• Utilizes innovative BAW sensor technology for superior performance.

Negative

• None.

GREENSBORO, N.C., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Qorvo^® (Nasdaq: QRVO), a leading global provider of connectivity and power solutions, 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 in Point-of-Care (POC) settings.

The test is authorized for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 (COVID-19) in nasal swab specimens from individuals who are suspected of COVID-19 within six days of symptom onset. The test is also authorized for individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days, with at least 24 hours and no more than 48 hours between tests. The FDA previously granted an EUA for use in moderate and high complexity settings such as laboratories. This EUA significantly expands the market for Qorvo beyond laboratories to include physician offices, urgent care centers, retail pharmacies, employee health testing, and any other locations where CLIA waived tests can be performed.

Erik Allen, recently appointed vice president of Qorvo and president of Qorvo Biotechnologies, said, "As the COVID testing market transitions to an endemic state and the increase in the omicron variant drives lower viral load, high quality rapid testing infrastructure is needed in POC settings. The Qorvo Omnia platform provides a unique combination of performance, automated workflow and scalability to serve on-site testing needs in a very efficient manner."

The Qorvo Omnia platform utilizes an innovative diagnostic technique by using high frequency Bulk Acoustic Wave (BAW) sensors to achieve highly sensitive and specific COVID-19 detection results with a fast turnaround time, in an easy to use, self-contained platform. BAW sensor technology enables low limit of detection (LOD) levels similar to molecular testing capability. As viral loads decrease particularly with the Omicron variant and sub-variants, low viral load in patient samples presents challenges for existing over-the-counter (OTC) lateral flow antigen tests, giving the Qorvo Omnia platform a technological advantage to continue to accurately detect antigen associated with COVID-19 during Omicron surges.

The Qorvo Omnia platform demonstrates excellent performance at the LOD (Limit of Detection) for the comparator PCR method. The Omnia platform demonstrated 85% sensitivity (PPA) during clinical studies to support the device Emergency Use Authorization at the Point of Care (POC); this NIH-sponsored study took place in the latter part of 2021. A separate NIH-sponsored research study was conducted during Omicron variant circulation at the beginning of 2022. During this study, Qorvo continued to see exemplary performance at 86% sensitivity where samples were at or above the LoD of the comparator PCR method. In all studies, 100% specificity was observed.

Peter Matos, president and CEO of medical consultancy Traeokos, said, “Qorvo’s antigen test brings the level of performance my clients need in multiple testing scenarios - especially as testing needs have evolved with Omicron variant performance challenges.”

For more information, visit https://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 for use in moderate and high complexity settings and as of July 2022 for Point of Care settings.

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 waived, 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) supplies innovative semiconductor solutions that make a better world possible. 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 consumer electronics, smart home/IoT, automotive, EVs, battery-powered appliances, network infrastructure, healthcare and aerospace/defense. Visit www.qorvo.com to learn how our diverse and innovative team is helping connect, protect and power our planet.

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.

Investor Relations Contact: Doug DeLieto VP, Investor Relations W +1-336-678-7968

Media Contact: Brent Dietz Qorvo Director of Corporate Communications W + 1 336-678-7935 brent.dietz@qorvo.com

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.

 

FAQ

What is the significance of the FDA's EUA for Qorvo's Omnia test?

The EUA allows Qorvo's Omnia SARS-CoV-2 Antigen Test to be used in Point-of-Care settings, broadening its market reach beyond laboratories.

How accurate is the Qorvo Omnia COVID-19 test?

The Omnia platform has shown 85% sensitivity in clinical studies, with 100% specificity, making it reliable for COVID-19 detection.

When was the EUA for the Omnia test granted?

The FDA granted emergency use authorization for the Qorvo Omnia test in July 2022.

What technology does the Qorvo Omnia test use?

The Qorvo Omnia test uses Bulk Acoustic Wave (BAW) sensor technology for sensitive and specific COVID-19 detection.

In what settings can the Qorvo Omnia test be used?

The Qorvo Omnia test can be used in physician offices, urgent care centers, retail pharmacies, and other CLIA-waived facilities.