QIAGEN’s NeuMoDx™ HAdV Quant Assay Secures CE-IVD Certification for Automated Testing to Detect Human Adenovirus Infections

• Important expansion of menu for NeuMoDx™ 96 and 288 Molecular Systems marks the 15^th assay with a CE-IVD marking, one of the largest menus available for integrated PCR testing

• Driving greater utilization of non-COVID-19 tests in Europe, U.S. and other markets

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its NeuMoDx™ HAdV Quant Assay for the identification and quantification of human adenovirus (HAdV) DNA has received CE-IVD certification for the European Union and other countries that accept this marking.

This milestone marks the 15^th assay available on the NeuMoDx™ 96 and 288 Molecular Systems, which is considered one of the broadest menus available among competitors. The tests can be run in true random access along with Laboratory Developed Tests (LDTs). Additional assays planned for CE-IVD launch in 2021 include Herpes Simplex Virus (HSV I/II), Human Herpesvirus 6 (HHV-6) as well as an FDA submission for Chlamydia & Gonorrhea (CT/NG).

Testing for the human adenovirus is critical since it can cause severe respiratory and other diseases in patients with weakened immune systems, a common consequence of organ transplantation.

The new HAdV Quant Assay was developed in partnership with Sentinel Diagnostics, an IVD company engaged in the development and production of diagnostic kits for Clinical Chemistry, Immunochemistry and Molecular Diagnostics. The availability of the HAdV assay strengthens the current NeuMoDx transplant assay menu that already includes CE-marked tests for cytomegalovirus (CMV), Epstein–Barr virus (EBV) and BK Virus (BKV) viral load monitoring for the management of immunocompromised patients, such as those who have undergone organ transplantation.

All of these assays make use of QIAGEN’s automated, three-step NeuMoDx solutions that extract DNA from blood or urine to isolate the target nucleic acids and then conduct a real-time polymerase chain reaction (RT-PCR) to target conserved sequences in the HAdV genome.

The NeuMoDx solutions currently offer CE-IVD tests for various viral and bacterial pathogens. Aside from assays for respiratory infections from SARS-CoV-2 to the 4-Plex test for Influenza A and B, RSV and SARS-CoV-2 covering the most common respiratory pathogens, there are tests for blood-borne viruses and post-transplant monitoring for CMV, EBV and BKV. The menu also features assays covering sexual and reproductive health including HPV and Chlamydia trachomatis.

Learn more about the NeuMoDx™ HAdV Quant Assay at https://go.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 March 31, 2021, QIAGEN employed approximately 5,700 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, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. 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.

Source: QIAGEN N.V.

Category: Corporate

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