QIAGEN has announced that it has received CE-IVDR certification for its complete QIAstat-Dx syndromic testing systems and panels. This includes an expanded Meningitis/Encephalitis (ME) Panel that sets a new benchmark in diagnosing central nervous system (CNS) infections.
With this milestone, the QIAstat-Dx system now offers CE-IVDR certified panels for respiratory, gastrointestinal, and CNS infections — enabling clinicians to diagnose infectious diseases more quickly and accurately.
The newly CE-IVDR certified QIAstat-Dx ME Panel delivers the broadest coverage available for CNS infections with 16 clinically relevant targets, including Cytomegalovirus (CMV) and Streptococcus pyogenes. The addition of CMV aligns the panel with current clinical needs, while S. pyogenes detection — exclusive to QIAstat-Dx — addresses an emerging and often overlooked pathogen in meningitis cases. The launch of this enhanced panel is scheduled for September 2025.
This announcement comes ahead of World Meningitis Day on October 5, reinforcing QIAGEN’s commitment to advancing rapid, reliable diagnostics for life-threatening CNS infections.
QIAstat-Dx can deliver fast, comprehensive results in about an hour, enabling clinicians to make earlier, accurate treatment decisions — helping reduce unnecessary antibiotic use, shorten hospital stays, and add value to both patient care 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 and 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.”
The CE-IVDR certification underscores QIAGEN’s commitment to maintaining the highest quality standards under the In Vitro Diagnostic Regulation (IVDR) framework, which replaces the older IVDD directive to enhance patient safety and transparency across the European Union.
QIAstat-Dx systems are designed for ease of use with minimal hands-on time, no reagent preparation, and reduced contamination risk — a key advantage when working with limited-volume samples like cerebrospinal fluid.
Currently available in over 100 countries, including the United States and throughout Europe, more than 4,600 QIAstat-Dx systems had been installed globally by the end of 2024. Hospitals, labs, and clinics value the platform for its simple workflow and reliable pathogen detection.
The system comes in two formats:
QIAstat-Dx Analyzer – integrates up to four Analytical Modules in one system
QIAstat-Dx Rise – a higher-capacity version supporting up to 160 tests per day with eight Analytical Modules
Both platforms received CE-marking under the IVDR framework late last year.