Press Release

Germantown, Maryland, and Hilden, Germany, October 13, 2022 -- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the certification of its leading in-vitro diagnostic (IVD) kit and its fully automated NeuMoDx platforms under the European Union’s new In-Vitro Diagnostic Medical Devices Regulation (IVDR) replacing the previous IVDD rules since May. The ipsogen JAK2 RGQ PCR Kit used for myeloproliferative neoplasms (MPN), a certain type of blood cancer, is now QIAGEN’s first IVD kit with IVDR CE-marking under Class C.

The updated set of rules that became effective May 26, 2022, is now imposing higher and broader requirements on IVD manufacturers to receive CE-marking for their products. For example, the change includes a new risk-based classification system that ranks all IVDs from A for lowest to D for highest risk, as well as a stronger oversight by independent EU-designated organizations, so-called Notified Bodies. With its more stringent mandates, the European regulatory framework comes closer to the FDA IVD regulations in the US. The new EU regulation will ensure a higher level of protection further reinforcing patient safety. It will allow laboratories to work with high-end reagents, further increasing the quality of their results.

QIAGEN is committed to the highest standards of quality and has therefore pledged full compliance with the new rules, which apply to all manufacturers commercializing IVD medical devices on the EU market. Last year QIAGEN completed the required audit of its quality management system (QMS) through a notified body without major observation – also related to IVDR – marking a first key milestone towards the company’s IVDR compliance. Based on this result, QIAGEN will continue to submit technical documentation in order to receive certifications across the entire IVD portfolio.

With the certification of its leading IVD kit and NeuMoDx platform, the company has now reached another significant milestone in its preemptive and meticulous campaign to timely transition over 180 products that fall within the scope of IVDR. The IVD kit is now classified under Class C, according to the new regulation. The ipsogen JAK2 RGQ PCR Kit provides highly sensitive and accurate leukemia biomarker detection, supporting the evaluation of suspected MPN patients, as well as monitoring those already diagnosed. The NeuMoDx rapid, integrated PCR testing platforms for mid- and high throughput are now classified under Class A and currently offer 16 regulated assays for different infectious diseases in Europe.

“Building on our extensive regulatory experience, QIAGEN experts across our business areas are working tirelessly to ensure QIAGEN’s global quality management and products are IVDR-ready and compliant,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “Our customers can expect to receive certified and approved products from QIAGEN, and will profit from improved clinical performance thanks to this enhanced, sustainable and transparent regulatory framework. In addition, they will benefit from our lab-developed test capabilities of our NeuMoDx offering that will not be impacted by the new regulatory framework.”

The transition period for IVDs has ended on May 26, 2022, but has been extended under certain conditions. However, European labs and clinicians supplied by QIAGEN can approach the transition with confidence, as the company has been at the forefront of developing and implementing the new regulations.

Following this significant step in the transition to new EU standards, passing the QMS audit and obtaining the product’s declaration of conformity, QIAGEN will now commence implementation of the updated labelling for these products over the coming month and will announce the release of individual products accordingly.

For more information about the transition from IVDD to IVDR and the corresponding time frame, please visit IVDR support site.

More information about the NeuMoDx molecular systems can be found 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 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).