QIAGEN Adds HSV1/2 Herpes Assay With CE-IVD Certification for Use on NeuMoDx Integrated PCR System

• NeuMoDx^™ HSV 1/2 Quant Assay now available for use to detect human herpes simplex virus type 1 and 2 Infections
• Addition of HSV 1/2 assay strengthens offering in viral load monitoring of immunocompromised patients
• QIAGEN now offering 15 CE-IVD assays for use on NeuMoDx^™ 96 and 288 systems in addition to capabilities to process laboratory-developed tests (LDT)

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its NeuMoDx HSV 1/2 Quant Assay for the quantification and differentiation of herpes simplex virus type 1 (HSV-1) DNA and/or herpes simplex virus type 2 (HSV-2) has received CE-IVD certification for the European Union and other countries that accept this marking.

This approval supports QIAGEN’s strategy to expand the menu of tests available for use on the NeuMoDx 96 and 288 Molecular Systems, which offer one of the broadest menus on the market now with 15 CE-IVD tests available.

The availability of the NeuMoDx HSV 1/2 Quant Assay also strengthens the comprehensive menu of transplant assays. These include CE-marked tests for cytomegalovirus (CMV), Epstein–Barr virus (EBV), BK Virus (BKV), and human adenovirus (hAdV) viral load monitoring for the management of immunocompromised patients such as organ transplant patients.

Additional assays planned for CE-IVD launch in 2022 include human herpesvirus 6 (HHV-6), and reformulated assays for Epstein-Barr virus (EBV) and combined respiratory panel test that can detect Influenza A / Influenza B / Respiratory Syncytial Virus (RSV) / SARS-CoV-2 virus.

Despite major advances in organ transplantation over the past four decades, herpesvirus infections remain a major cause of post-operative mortality. Testing for HSV-1/2 infections is especially critical in transplant recipients with weakened immune systems.

The new HSV 1/2 Quant Assay was developed in partnership with Sentinel Diagnostics, a company engaged in the development and production of In Vitro Diagnostic kits for clinical chemistry, immunochemistry and molecular diagnostic platforms.

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 HSV genome.

Aside from assays for post-transplant monitoring the NeuMoDx solutions currently offer CE-IVD tests for detection and quantitation of blood-borne viruses (HIV, HCV, and HBV). The menu also features assays for various viral and bacterial pathogens 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, and sexual and reproductive health including HPV and Chlamydia trachomatis.

Learn more about the NeuMoDx HSV 1/2 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), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of March 31, 2022, QIAGEN employed more than 6,000 people in over 35 locations worldwide. Further information can be found at https://www.qiagen.com/.

About Sentinel Diagnostics

Sentinel Diagnostics (Sentinel CH. S.p.A) is an Italian company based in Milan focused on the development and production of In Vitro Diagnostics with more than 35 years’ experience. Sentinel Diagnostics offers a wide portfolio of kits for the most advanced Clinical Chemistry and Immunochemistry platforms, the FOB Gold^® line for colorectal cancer screening and the STAT-NAT^® ready to use and eco-friendly Molecular Diagnostics kits. For more information, visit www.sentineldiagnostics.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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