• NeuMoDx MPXV Test Strip enables researchers to quickly identify both clade I & II of the monkeypox virus

• Dual-target design to reduce false negatives

• Multiplex test strengthens QIAGEN’s portfolio designed to boost the fight against global monkeypox outbreak

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the monkeypox (MPXV) test for its NeuMoDx automated PCR platform to strengthen surveillance and research into the current outbreak in non-endemic regions that has infected tens of thousands of people all over the world since first being identified in May 2022.

The NeuMoDx MPXV Test Strip – currently for research use only (RUO) – is a multiplex test that identifies both clades (variants) of monkeypox. It is designed as a dual-target assay to reduce false negative results, incorrectly indicating the absence of the virus. It differentiates between the clade I and clade II variants, delivering first results in around 70 minutes on QIAGEN’s easy to use, fast and flexible NeuMoDx 96 and NeuMoDx 288 Molecular Systems.

“NeuMoDx MPXV enables researchers the fast and reliable qualitative detection and differentiation of both monkeypox clades, a huge help for those trying to understand and contain this virus,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN.

The NeuMoDx assay extracts DNA from lesion fluid swabs to isolate the target nucleic acids and then conducts a real-time polymerase chain reaction. NeuMoDx has a simple 3-step workflow. Test strips and core reagents and consumables are ready-to-use, can remain on board for a minimum of 7 days and can be loaded whilst the system is operating. The NeuMoDx system is always ready to run and offers true random access testing capabilities, has up to 8 hours walkaway time and produces minimal waste. The system can run up to 30 different assays and offers the versatility to run IVD certified assays, self-developed tests (SDTs) and RUO assays.

QIAGEN has been working with healthcare authorities around the world since the global monkeypox outbreak began this spring to contribute its broad testing portfolio and expertise as a trusted partner in an urgent global health response. Its new assay joins a portfolio that addresses all testing needs. QIAGEN this summer launched the QIAstat-Dx Viral Vesicular Panel RUO, the world’s first syndromic test, for research use only, to differentiate between monkeypox and five other pathogens that cause similar symptoms.

QIAGEN’s sample-technology kits, testing components and instruments are also being used by public health agencies to develop their own tests. The NeuMoDx clinical PCR system can run these so-called self-developed tests (SDTs), while enabling molecular diagnostic laboratories to process ever-larger volumes and deliver ever-faster insights into monkeypox and other infectious diseases.

Some 78,000 people in more than 110 countries have been infected with the virus since the latest outbreak began this spring, according to the World Health Organization (WHO). The sustained global transmission is different from other outbreaks recorded since the 1970s. Should authorities open new pathways in light of this public-health emergency, QIAGEN stands ready to widen the availability of its applications beyond researchers to healthcare professionals treating patients in clinical settings.

To learn more about the NeuMoDx MPXV Test Strip, please visit: https://www.qiagen.com/applications/automated-pcr/assay-menu/monkeypox

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 September 30, 2022, QIAGEN employed more than 6,200 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).

Source: QIAGEN N.V.

Category: Corporate

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