QIAGEN achieves European IVDR certification for QIAstat-Dx syndromic testing devices and assays

Venlo, Netherlands, Sept. 26, 2024 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QIAstat-Dx syndromic testing systems and related assays have received CE marking under the European Union’s new In Vitro Diagnostic Medical Devices Directive ( IVDR).

This certification includes the widely used QIAstat-Dx Analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory diseases. This achievement underscores QIAGEN’s commitment to meeting the highest standards of safety, quality and performance, as it has transitioned 80 percent of more than 180 products into the new regulatory framework.

The new IVD regulation aims to ensure the safety, quality and effectiveness of in vitro diagnostic (IVD) devices regulated by independent bodies known in the EU as Notified Bodies. Devices are now classified by risk level, from A (lowest risk) to D (highest risk). QIAstat-Dx devices, QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise are classified as Class A devices, while QIAstat-Dx Gastrointestinal Panel 2 is classified as a Class C device. QIAstat-Dx Respiratory Panel Plus is classified as a Class D device, the highest risk category, highlighting QIAGEN’s capabilities to meet the highest regulatory thresholds in Europe. Application for IVDR certification of the QIAstat‑Dx Meningitis/Encephalitis Panel is expected in the coming months.

“Achieving IVDR certification for our QIAstat-Dx systems and panels is a significant milestone for QIAGEN,” said Fernando Beils, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “This certification, under the new, more stringent EU regulatory framework, confirms our commitment to providing healthcare professionals with reliable and rapid syndromic testing solutions they can trust. As we continue to transition over 180 products into the IVDR framework, we provide our clinical customers with a wide range of diagnostic products that meet the highest standards of safety, quality and performance.” “We are committed to improving patient care by offering a portfolio of solutions.”

The QIAstat-Dx system utilizes multiplex real-time PCR technology to rapidly detect and identify multiple pathogens simultaneously, delivering results in approximately one hour. It provides comprehensive data, including cycle threshold (Ct) values ​​and amplification curves, directly on the device touch screen. These rapid and accurate results allow healthcare providers to make informed treatment decisions, such as stopping unnecessary antibiotic use when viral infections are detected, thereby contributing to better patient outcomes and antimicrobial stewardship.

Available in more than 100 countries, including the US and Europe, QIAstat-Dx solutions play a critical role in disease diagnosis worldwide. By the end of 2023, more than 4,000 QIAstat-Dx systems have been installed worldwide. Hospitals, laboratories and clinics value the QIAstat-Dx range for its ease of use and reliable detection of a wide range of pathogens.

QIAstat-Dx is available in two formats: the QIAstat-Dx edition, which combines up to four Analytical Modules in one integrated system, and the QIAstat-Dx Rise high-capacity edition, which provides comprehensive testing for up to 160 tests per day using eight. Analytical Modules.

For more information about the transition from IVDD to IVDR and the associated timeframe, please visit QIAGEN’s IVDR support site.

More information about QIAstat-Dx can be found at https://www.qiagen.com/de-gb/applications/syndromic-testing.

About QIAGEN

QIAGEN NV, a Netherlands-based holding company, is a leading global provider of Sample to Insight solutions that enable customers to extract valuable molecular information from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Testing technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions connect these in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers worldwide in Molecular Diagnostics (human health) and Life Sciences (academia, pharmaceutical R&D and industrial applications, especially forensics). As of June 30, 2024, QIAGEN employed more than 5,900 people in more than 35 locations worldwide. You can find more information at: https://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be deemed 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. Any statements contained herein regarding QIAGEN products (including products used in response to the COVID-19 pandemic) are based on expected adjusted net worth to the extent they relate to launch and development timing, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion. collaborations, markets, strategy or operating results, including but not limited to sales and adjusted diluted earnings results, are forward-looking; Such statements are based on current expectations and assumptions that involve certain uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks related to growth management and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), risks related to variability of operating results and allocations between customer classes, business development. introducing markets for our products to customers in academia, pharmaceuticals, 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 products (including fluctuations due to general economic conditions, the level and timing of customers’ financing, budgets and other factors); our ability to obtain regulatory approval for our products; difficulties in successfully adapting QIAGEN products into integrated solutions and manufacturing such products; QIAGEN’s ability to identify and develop new products and to differentiate and protect our products from those of competitors; market acceptance of QIAGEN’s new products and integration of acquired technologies and businesses; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises (including the scope and duration of the COVID-19 pandemic and its impact on demand for our products and other aspects of our business) or other force majeure events; the possibility that anticipated benefits related to recent or pending acquisitions may not be realized as expected; and other factors discussed under the heading “Risk Factors” in Item 3 of our most recent Annual Report on Form 20-F. For more information, please see discussions in reports QIAGEN files or files with the U.S. Securities and Exchange Commission.

Source: QIAGEN NV
Category: Corporate