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QIAGEN Receives FDA Emergency Use Authorization for NeuMoDx Multiplex Test Expanding COVID-19 Portfolio

March 29, 2021
  • NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test receives Emergency Use Authorization by FDA
  • The 4-plex test utilizes the high-throughput, automated testing capabilities of the NeuMoDx systems, which has a growing and comprehensive assay menu for respiratory, blood-borne virus, transplant, and reproductive health disease areas
  • Test adds to QIAGEN’s expanding portfolio of PCR testing solutions for COVID-19 testing

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the Emergency Use Authorization by the U.S. FDA for the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 VantageAssay that will help healthcare professionals quickly identify and differentiate individuals suspected by a healthcare provider of respiratory viral infection consistent with COVID-19.

As restrictions are eased and social distancing measures are reduced, respiratory viral infections are likely to increase. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza or RSV can be similar. This makes it essential to correctly identify them in order to treat and manage patients accordingly, especially in the COVID-19 pandemic. This polymerase chain reaction (PCR) multiplex test will be an important tool now and in upcoming winter seasons for simultaneous qualitative detection and differentiation of influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes.

QIAGEN launched the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test in the European Union and other markets that accept CE-IVD in November 2020 and will now begin commercialization of the test in the U.S.

QIAGEN’s new respiratory test takes advantage of the NeuMoDx 96 and NeuMoDx 288 molecular systems’ automated three-step workflow. Coupled with additional system features ­­– like processing capacity, true random access, and continuous loading of samples, reagents and consumables while the system is running – the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 VantageAssay will be a powerful diagnostic tool for the flu season and COVID-19 pandemic.

“The authorization of this new test will become a pivotal tool for the detection and differentiation of SARS-CoV-2 from influenza like illnesses, or ILls,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. “This test will play an important role in differentiating between ILI’s while the burden of COVID-19 continues. With its ease of use and true random access, the NeuMoDx will help laboratories maintain throughput for this increased testing volume while continuing routine testing. Also, with the continued ramp up of our manufacturing capacity, the NeuMoDx will be ready to answer the needs of molecular diagnostic laboratories for 2021 and beyond.”

The new 4-plex test joins a growing menu of assays on the NeuMoDx platform, which includes tests for blood-borne viruses, sexual and reproductive health, transplant and immunocompromised disease areas. More tests are in development and expected to launch in the coming months, including VZV, adenovirus and others.

QIAGEN fully acquired NeuMoDx in September 2020 and made it one of its five growth drivers for the company to continue growing on a standalone basis – the others being Sample Prep, QIAcuity, QFT and QIAstat-Dx. The NeuMoDx™ Flu A-B/RSV/ SARS-CoV-2 VantageTest strengthens QIAGEN’s footprint in PCR, the gold standard in coronavirus testing.

QIAGEN has a broad portfolio of testing and research solutions for COVID-19, ranging from fast singleplex and multiplex PCR tests to fast syndromic solutions (QIAstat-Dx), providing customers with a broad variety of PCR-based testing options. Furthermore, the portfolio includes RNA extraction kits and instruments as well as testing components and enzymes used by third parties for their own PCR test kits. QIAGEN’s COVID-19 portfolio also includes the QIAreach Antibody and Antigen tests, as well as SARS-CoV-2 T-Cell tests based on the QuantiFERON IGRA technology. In October 2020, the company also launched QIAprep&amp which streamlines PCR workflows by integrating sample preparation and real-time PCR detection into a single kit. QIAGEN also provides NGS solutions for research into mutations of COVID-19, dPCR solutions for wastewater testing and bioinformatics with QDI.

Further information on QIAGEN’s response to the coronavirus outbreak can be found here.

For more information on the NeuMoDx platform and NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test,please visit http://qiagen.com/NeuMoDx

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of December 31, 2020, QIAGEN employed more than 5,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

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