QIAGEN launches NeuMoDx multiplex test to complete range of SARS-CoV-2 testing solutions in Europe and other markets
Nov 16 2020

QIAGEN launches NeuMoDx multiplex test to complete range of SARS-CoV-2 testing solutions in Europe and other markets

• Fast and easy-to-use respiratory PCR test comes onto market as flu season gains pace in Northern Hemisphere
• CE-IVD marking in Europe granted for NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test, has also been submitted to FDA for Emergency Use Authorization
• Test adds to QIAGEN’s growing portfolio of PCR testing solutions for COVID-19 testing
• QIAGEN also expands sample type claim for NeuMoDx™ SARS-CoV-2 test to include saliva from a dedicated collection kit in Europe

Germantown, Maryland, and Hilden, Germany, November 16, 2020 –QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the European launch of the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test that will help healthcare professionals quickly identify and differentiate between patients with common seasonal respiratory infections and COVID-19.

With the Northern Hemisphere in the grip of flu season, this multiplex polymerase chain reaction (PCR) test detects and differentiates influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes. These viruses produce similar respiratory symptoms, making it essential to provide differential diagnosis among them for patient treatment and management decisions, especially in the COVID-19 pandemic.

QIAGEN has launched NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage in the European Union and other markets after CE-IVD registration, and has submitted an Emergency Use Authorization (EUA) request to the FDA.

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 Vantage test will be a powerful diagnostic tool for the flu season and COVID-19 pandemic.

In addition, QIAGEN has expanded specimen types that can be used on the existing NeuMoDx™ SARS-CoV-2 test. CE-IVD approval has been obtained for the use of saliva samples collected with the NeuMoDx™ Saliva Collection Kit, which includes a collection vial, stabilization tube and pipette.

This kit allows for less invasive sample collection compared to commonly used nasal swabs. It reduces the burden on the supply of the nasal collection devices and increases laboratory testing capacity. This claim extension for the saliva collection kit is also in review with the FDA. The singleplex test was granted an EUA in March.

“Both launch and label extension expand the capabilities of our NeuMoDx systems in detection of COVID-19,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “They add to our growing NeuMoDx testing menu, which in 2020 included launches for HIV-1, TV/MG, Strep A/C/G, HPV, BK virus, and Influenza A-B/RSV. We will launch additional assays in 2021 and continue to increase the value of the platform for lab customers beyond the pandemic.

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

QIAGEN now is the only company to be able to offer fast singleplex and multiplex PCR tests as well as a fast syndromic solution (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. In October, QIAGEN also launched QIAprep&amp which streamlines PCR workflows by integrating sample preparation and real-time PCR detection into a single kit. The product has initially been launched for research use only and is planned to gain EUA and CE-IVD registration soon.

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 Assay 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 September 30, 2020, QIAGEN employed more than 5,300 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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