CE Mark Granted to Qiagen’s QIAstat-Dx Syndromic Testing Instruments, Assays

QIAGEN’s QIAstat-Dx syndromic testing systems and associated assays have earned CE marking under the European Union’s new In-Vitro Diagnostic Medical Devices Regulation (IVDR).
 
The certification includes the QIAstat-Dx Analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory illnesses. The company has already transitioned 80% of more than 180 products to the new regulatory framework.
 
“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 rigorous EU regulatory framework underscores our commitment to provide healthcare professionals with reliable and rapid syndromic testing solutions they can trust. As we continue to transition over 180 products to the IVDR framework, we remain dedicated to enhancing patient care by offering clinical customers a broad portfolio of diagnostic solutions that meet the highest standards of safety, quality, and performance.”

The new IVD regulation aims to ensure the safety, quality and effectiveness of in-vitro diagnostic (IVD) devices, overseen by Notified Bodies. Devices are now classified by risk level, from A (lowest risk) to D (highest risk). The QIAstat-Dx instruments, QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise, are classified as Class A devices, while the QIAstat-Dx Gastrointestinal Panel 2 is classified as a Class C device. The QIAstat-Dx Respiratory Panel Plus is classified as a Class D device (the highest risk category). The submission for IVDR certification of the QIAstat‑Dx Meningitis/Encephalitis Panel is expected in the next several months.
 
The QIAstat-Dx system leverages 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 instrument’s touch screen. These fast and precise results enable healthcare providers to make informed treatment decisions, such as discontinuing 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 United States and throughout Europe, QIAstat-Dx solutions help diagnose disease. By the end of 2023, more than 4,000 QIAstat-Dx systems had been installed globally. 
 
QIAstat-Dx is available in two formats: The QIAstat-Dx version, which combines up to four Analytical Modules in one integrated system, and the QIAstat-Dx Rise higher-capacity version that provides comprehensive testing for up to 160 daily tests using eight Analytical Modules.
 
QIAGEN N.V., a Netherlands-based holding company, is a global provider of Sample to Insight solutions that enable customers to gain molecular insights from samples containing the building blocks of life. The firm’s 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. QIAGEN provides solutions to more than 500,000 customers worldwide in molecular diagnostics (human healthcare) and life sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2024, QIAGEN employed more than 5,900 people in over 35 locations globally.