QIAGEN Launches Rapid GI Infection Test in the US, Approved by FDA

QIAGEN (NYSE:QGEN, Frankfurt Prime Standard: QIA)))) today announced the launch of the QIAstat-Dx Gastrointestinal Panel 2 in the United States. The launch comes after the recent clearance of the syndromic test for

QIAGEN (NYSE:QGEN, Frankfurt Prime Standard: QIA))))) today announced the launch of the QIAstat-Dx Gastrointestinal Panel 2 in the United States. The launch comes after the recent clearance of the syndromic test for clinical use by the U.S. Food and Drug Administration (FDA) and marks a significant step forward in improving the accuracy and efficiency of gastrointestinal (GI) infection diagnosis.

The QIAstat-Dx Gastrointestinal Panel 2 takes about an hour to simultaneously look for up to 16 clinically relevant bacterial, viral and parasitic pathogens that cause most GI infections. Acute infectious gastroenteritis is a common reason for hospitalizations and outpatient physician visits in the U.S., with an estimated 180 million cases per year.[1]

The panel leverages QIAstat-Dx’s ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction – an important advance compared to traditional microbiological testing, which often requires samples to be incubated for at least 24 hours and up to 10 days of specimen collection. Software interprets signals from the reaction and provides positive or negative results for each pathogen. QIAstat-Dx additionally provides easy-to-view cycle threshold (Ct) values and amplification curves that can offer additional insights not available with end-point PCR or other techniques.

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