QIAGEN Adds New Assays With CE-IVD Certification for NeuMoDx Integrated PCR System

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced new additions to its comprehensive NeuMoDx assay menu for organ transplant-associated viruses. The new assays for the identification and quantification of the Epstein-Barr virus (EBV) and the human herpesvirus 6 (HHV-6) have received CE-IVD certification for the European Union and other countries that accept this marking.

The new assays support QIAGEN’s strategy of expanding the menu of tests available for use on the NeuMoDx 96 and 288 Molecular Systems. With 16 EU-certified in-vitro diagnostics (CE-IVD) tests available, the systems already offer one the broadest selections of tests on the market.

The assay menu for transplant-associated viruses is used for the viral load monitoring for the management of immunocompromised patients such as organ transplant patients. Diseases caused by the Epstein-Barr virus can cause major complications in organ transplant recipients, whose immune systems are weakened. While medical science has achieved major advances in organ transplantation over the past four decades, herpesvirus infections remain a major cause of post-operative mortality.

The assay menu also includes CE-marked tests for cytomegalovirus (CMV), BK Virus (BKV), human adenovirus (hAdV) as well as herpes simplex virus type 1 (HSV-1) and/or herpes simplex virus type 2 (HSV-2).

Continuously expanding assay capabilities

In addition to the NeuMoDx assays planned, the Monkeypox RUO Assay will launch in 2022 as a commercial multiplex assay for research and surveillance of the two known forms of currently circulating monkeypox virus (Clade I and Clade II). The assay adds to the broad portfolio that QIAGEN offers to address all testing needs around monkeypox.

QIAGEN remains committed to responding to the COVID-19 endemic by preparing to launch a new multiple-target test: NeuMoDx FluA/FluB/RSV/SARS-CoV-2 Assay with a new dual-target SARS-CoV-2 design. The assay simultaneously detects and differentiates the two most common strains of influenza (A and B), respiratory syncytial virus (RSV) and SARS-CoV-2 from individuals suspected by a health care provider of respiratory viral infection. The new dual target design aims to improve the assay robustness to lower the risk of future SARS-CoV-2 variants impacting assay performance.

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). The NeuMoDx assay menu is designed to completely automate workflows with less waste in labs. Based on a microfluidic cartridge it allows running of 12 reactions at once. Results appear in about one hour with up to eight hours of walk-away time.

Aside from assays for transplant-associated viruses and respiratory infections, the NeuMoDx solutions currently offer CE-IVD tests for blood-borne viruses and assays covering sexual and reproductive health including HPV and Chlamydia trachomatis.

To find out more about the NeuMoDx assay menu, please visit 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), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of June 30, 2022, QIAGEN employed more than 6,100 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).

Category: Corporate

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