Qiagen secures European CE-IVDR certification for full QIAstat-Dx portfolio

Qiagen (QGEN) “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 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 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.”