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

• New assays for Epstein-Barr virus (EBV) and human herpesvirus 6 (HHV-6) expand menu to now 16 available CE-IVD assays

• Improved multiple-target assay for respiratory diseases in development; new dual-target SARS-CoV-2 design enables faster clinical decisions

• Multiplex assay for detection of monkeypox planned to be made available in 2022

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

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Category: Corporate

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