QIAGEN Secures CE-IVDR Certification for Full QIAstat-Dx Portfolio, Expands Diagnostic Leadership with Enhanced Meningitis/Encephalitis Panel
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) has announced a significant regulatory milestone: the company has secured CE-IVDR certification for its entire QIAstat-Dx syndromic testing portfolio. This achievement covers all of the system’s diagnostic panels, including a newly expanded Meningitis/Encephalitis (ME) Panel, which is set to raise the bar in the detection and diagnosis of central nervous system (CNS) infections.
The announcement underscores QIAGEN’s strong commitment to quality, regulatory compliance, and innovation in infectious disease diagnostics. The certification not only strengthens QIAGEN’s leadership position in the European molecular diagnostics market but also reinforces the company’s global reputation as a trusted partner for healthcare providers seeking reliable, rapid, and actionable testing solutions.
Expanded Panel for CNS Infections
Among the highlights of this regulatory success is the newly expanded QIAstat-Dx Meningitis/Encephalitis (ME) Panel, which will officially launch in September 2025. This panel now provides the broadest available coverage for CNS infections by detecting 16 clinically relevant pathogens, ranging from viruses and bacteria to fungi. Notably, the panel includes cytomegalovirus (CMV) and Streptococcus pyogenes (S. pyogenes).
- CMV detection aligns the panel with pressing clinical needs, given the virus’s role in immunocompromised patients and neonates.
- S. pyogenes detection is unique to QIAstat-Dx and addresses a pathogen that is increasingly recognized as an underdiagnosed cause of meningitis.
By incorporating these critical targets, QIAGEN has ensured that clinicians will have access to a diagnostic tool that delivers both breadth and precision—qualities that are indispensable in time-sensitive CNS infection cases.
Timely Launch Aligned with Global Awareness
The clearance arrives just weeks before World Meningitis Day on October 5, a global event dedicated to raising awareness of meningitis and its devastating effects. Each year, meningitis claims lives or leaves survivors with long-term complications, making early detection a matter of life and death. QIAGEN’s expanded ME panel is expected to make a meaningful contribution to the fight against these diseases by offering clinicians a faster, more comprehensive, and more reliable diagnostic pathway.
Speed, Accuracy, and Clinical Value
One of the defining features of the QIAstat-Dx system is its ability to deliver comprehensive results in about an hour. Traditional culture-based diagnostics or stepwise testing approaches often take days to yield results, delaying critical treatment decisions. In contrast, QIAstat-Dx empowers clinicians to rapidly identify pathogens, start appropriate therapies earlier, and reduce reliance on broad-spectrum antibiotics.
This has multiple advantages:
- Improved patient outcomes through targeted therapies.
- Reduced hospital stays due to faster recovery and fewer complications.
- Healthcare system savings through better resource allocation.
- Support for antimicrobial stewardship by cutting down unnecessary antibiotic use.
“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.”
Understanding CE-IVDR Certification
The In Vitro Diagnostic Regulation (IVDR) is the European Union’s updated regulatory framework for diagnostic devices, replacing the earlier In Vitro Diagnostic Directive (IVDD). Unlike its predecessor, IVDR introduces stricter requirements for safety, performance, and transparency, ensuring that diagnostic products meet the highest standards for clinical reliability.
For QIAGEN, securing IVDR certification across its entire QIAstat-Dx portfolio represents more than a regulatory box checked. It signals to laboratories, clinicians, and patients that these products have undergone the most rigorous validation available in Europe. The certification further enhances QIAGEN’s credibility as a partner that prioritizes both innovation and compliance.
Distinctive Advantages of QIAstat-Dx
QIAGEN’s QIAstat-Dx system stands out in the syndromic testing market for several reasons:
- Exclusive Targets – The inclusion of medically valuable markers such as S. pyogenes provides clinicians with insights not available on competing platforms.
- Simplified Workflow – No reagent preparation is required, minimizing hands-on time and reducing contamination risks.
- Suitability for Critical Samples – Particularly relevant for CNS testing, where samples like cerebrospinal fluid are often collected invasively and in limited amounts.
- Flexibility of Use – Designed to serve the needs of both small hospital laboratories and large-scale diagnostic centers.
These advantages position QIAstat-Dx as a comprehensive, reliable, and user-friendly solution in a healthcare environment where time and accuracy are critical.
Global Adoption and Reach
The QIAstat-Dx system has already established a strong global presence. As of the end of 2024, more than 4,600 systems were installed worldwide, spanning hospitals, laboratories, andhttps://thepharmadata.com/qiagen-enhances-digital-pcr-lineup-with/ clinical centers. The platform is currently available in over 100 countries, including key markets in the United States and across Europe.
The system comes in two main configurations:
- QIAstat-Dx Analyzer: Integrates up to four analytical modules into a single system, suitable for mid-volume testing.
- QIAstat-Dx Rise: A higher-capacity system designed to support up to 160 tests per day with eight analytical modules, ideal for larger institutions.
Both configurations have already secured CE-marking under the IVDR framework, reinforcing their reliability and compliance.
The Broader Impact on Infectious Disease Diagnostics
The certification and panel expansion reflect broader trends in the healthcare and diagnostics industry:
- Syndromic testing is becoming a standard of care. Clinicians increasingly value panels that can simultaneously detect multiple pathogens associated with a clinical syndrome.
- Rapid diagnostics play a critical role in public health. Infections such as meningitis, influenza, and gastrointestinal diseases can spread quickly and require timely intervention.
- Global antimicrobial resistance (AMR) challenges. By supporting appropriate use of antibiotics, syndromic testing directly contributes to international efforts to combat AMR.
QIAGEN’s move thus not only strengthens its commercial offerings but also supports global healthcare priorities.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions. The company’s technologies enable customers to extract, process, and analyze molecular information from biological samples containing DNA, RNA, and proteins.
Key pillars of QIAGEN’s business include:
- Sample Technologies – Isolation and processing of biomolecules from blood, tissue, and other materials.
- Assay Technologies – Preparation of biomolecules for advanced analysis.
- Bioinformatics – Tools to interpret complex biological data and provide actionable insights.
- Automation Solutions – Integrated workflows that improve efficiency and reduce costs.
QIAGEN serves more than 500,000 customers worldwide across two primary markets:
- Life Sciences – Supporting academic research, pharmaceutical R&D, and industrial applications such as forensics.
- Molecular Diagnostics – Providing solutions that guide clinical decision-making and patient management.
As of June 30, 2025, QIAGEN employed approximately 5,700 people across more than 35 global locations. For more information, visit www.qiagen.com.
The CE-IVDR certification of the entire QIAstat-Dx portfolio, combined with the launch of the expanded Meningitis/Encephalitis Panel, marks a pivotal moment for QIAGEN and for healthcare providers across Europe. By ensuring faster, more comprehensive, and more reliable infectious disease diagnostics, QIAGEN is not only meeting regulatory requirements but also fulfilling its mission to improve patient outcomes worldwide.
With installations already widespread and a growing reputation for innovation, QIAstat-Dx is positioned to remain a cornerstone of modern molecular diagnostics—bridging the gap between laboratory insights and frontline clinical care.
