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QIAGEN Secures European IVDR Certification for QIAstat-Dx Syndromic Testing Systems and Assays

NextEdge Admin

27 Sep 2024

3 min 30 sec

QIAGEN has announced that its QIAstat-Dx syndromic testing systems and associated assays have been CE-marked under the European Union’s new In-Vitro Diagnostic Medical Devices Regulation (IVDR). This certification includes the QIAstat-Dx Analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory illnesses. With 80% of its over 180 products transitioned to the new regulatory framework, QIAGEN reaffirms its commitment to meeting the highest standards of safety, quality, and performance in diagnostics.

The IVDR, which aims to enhance the safety, quality, and effectiveness of in-vitro diagnostic (IVD) devices, classifies products by risk, from Class A (lowest) to Class D (highest). QIAstat-Dx instruments, such as the 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 Class C. The QIAstat-Dx Respiratory Panel Plus, classified as a Class D device, meets the most stringent regulatory requirements, reflecting QIAGEN’s ability to comply with the highest safety and quality thresholds in Europe. Additionally, QIAGEN plans to submit the QIAstat-Dx Meningitis/Encephalitis Panel for IVDR certification in the coming months.

Fernando Beils, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area, noted that achieving IVDR certification marks a significant milestone. The rigorous certification under this new EU regulatory framework reflects QIAGEN's commitment to providing healthcare professionals with reliable, fast, and accurate syndromic testing solutions. By continuing to transition products to IVDR standards, QIAGEN is enhancing patient care through a broad portfolio of safe and effective diagnostic solutions.

The QIAstat-Dx system uses multiplex real-time PCR technology to detect and identify multiple pathogens simultaneously, delivering results in about one hour. This fast turnaround time helps healthcare providers make informed decisions, such as discontinuing unnecessary antibiotics for viral infections, promoting better patient outcomes and supporting antimicrobial stewardship.

With over 4,000 QIAstat-Dx systems installed worldwide by the end of 2023, QIAGEN’s solutions are valued in hospitals, laboratories, and clinics for their ease of use and accurate pathogen detection. The system is available in two formats: a version with four Analytical Modules, and the higher-capacity QIAstat-Dx Rise, which can handle up to 160 tests per day using eight modules.