QIAGEN Secures European CE-IVDR Certification for Full QIAstat-Dx Portfolio

Original from: business wire

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it has achieved CE-IVDR certification for its full portfolio of QIAstat-Dx syndromic testing systems and panels, including an expanded Meningitis/Encephalitis (ME) Panel that sets a new benchmark in the diagnosis of central nervous system (CNS) infections.

The QIAstat-Dx system now offers CE-IVDR certified panels for respiratory, gastrointestinal and CNS infections that help clinicians diagnose infectious diseases with greater speed and accuracy.

Marking the latest clearance, the expanded CE-IVDR QIAstat-Dx ME Panel provides the broadest coverage available for CNS infections with 16 clinically relevant targets. These include cytomegalovirus (CMV) and Streptococcus pyogenes. The inclusion of CMV further aligns the panel with current clinical needs, while S. pyogenes detection – exclusive to QIAstat-Dx – addresses an increasingly important and often overlooked pathogen in meningitis cases. The launch of this enhanced panel is expected in September 2025.

The clearance comes ahead of World Meningitis Day on October 5, underscoring the commitment of QIAGEN to advancing rapid and reliable diagnostics for life-threatening CNS infections.

QIAstat-Dx can deliver fast and comprehensive results in about an hour, empowering clinicians to make early and accurate treatment decisions that help avoid unnecessary antibiotic use and support shorter hospital stays and bringing clear value to both patients and healthcare systems.

"Achieving IVDR certification for our complete QIAstat-Dx portfolio marks a major milestone for QIAGEN and the laboratories and clinicians we serve," said Nadia Aelbrecht, Vice President, Head of Infectious Diseases at QIAGEN. "This certification demonstrates our commitment to meeting the highest regulatory standards while reinforcing our dedication to delivering innovative diagnostics that improve patient care."

CE-IVDR certification of these impactful tests reflects QIAGEN’s commitment to providing reliable diagnostics that meet the highest quality standards. The European Union has implemented a new law that harmonizes the requirements for in vitro diagnostics (IVD) devices in Europe, replacing the old directive to improve patient safety and transparency. For more information about QIAGEN’s transition from IVDD to IVDR and the corresponding time frame, please visit the IVDR support site.

QIAstat-Dx provides unique advantages for clinicians and laboratories, including exclusive, medically valuable targets and the market’s easiest workflow. The simple process requires no reagent preparation and minimal hands-on time, helping reduce the risk of contamination, especially critical when working with limited-volume samples that need to be collected invasively, like cerebrospinal fluid.

Available in over 100 countries, including the U.S. and throughout Europe, QIAstat-Dx solutions play a critical role in disease diagnosis worldwide. By the end of 2024, more than 4,600 QIAstat-Dx systems had been installed globally. Hospitals, laboratories, and clinics value the QIAstat-Dx range for its ease of use and reliable detection of a wide array of pathogens.

The widely used QIAstat-Dx system is available in two formats: The QIAstat-Dx Analyzer version that brings together up to four Analytical Modules into one integrated system, and the QIAstat-Dx Rise higher-capacity version that provides comprehensive testing for up to 160 tests per day using eight Analytical Modules. Both platforms received CE-marking under IVDR framework late last year.

Source: QIAGEN Secures European CE-IVDR Certification for Full QIAstat-Dx Portfolio