February 2025—Qiagen announced that the FDA has cleared its QIAstat-Dx meningitis/encephalitis panel for clinical use. The panel simultaneously analyzes several of the most common viral, bacterial, and fungal pathogens responsible for community-acquired meningitis/encephalitis.
In a separate release, the company announced FDA clearance of the first in a series of QIAstat-Dx gastrointestinal panel tests for clinical use. The QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (bacterial and viral) covers Campylobacter, Salmonella, Shiga-like toxin E. Coli (STEC), Shigella, and Norovirus. Qiagen says it plans to submit a second version of the gastrointestinal panel, covering five common bacterial pathogens that cause gastrointestinal infections, to the FDA for clearance. The company also plans to submit the QIAstat-Dx Rise for FDA clearance early this year.
The panels run on the QIAstat-Dx, which delivers results in about one hour and with less than one minute of hands-on time. Cycle threshold values and amplification curves provide additional information and are instantly viewable on the instrument touchscreen with no additional software required.
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