Qiagen NV Secures CE-IVDR Certification for Full QIAstat-Dx Portfolio, Setting New Standard in CNS Infection Diagnostics
Reuters
Sep 11
Qiagen NV Secures CE-IVDR Certification for Full QIAstat-Dx Portfolio, Setting New Standard in CNS Infection Diagnostics
Qiagen NV has secured the European CE-IVDR certification for its entire portfolio of QIAstat-Dx syndromic testing systems and panels, including an expanded Meningitis/Encephalitis (ME) Panel. This certification underscores Qiagen's commitment to providing high-quality diagnostics and aligns with the new European Union regulations for in vitro diagnostics. The QIAstat-Dx panels offer quick and comprehensive results, facilitating early and accurate treatment decisions. The newly certified ME Panel, which provides broad coverage for CNS infections with 16 targets, is set to launch in September 2025. This regulatory approval highlights Qiagen's dedication to advancing diagnostics for life-threatening central nervous system infections.
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