Jan. 14, 2025—Qiagen 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. The panel runs 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 in the context of co-infections and are instantly viewable on the instrument touchscreen with no additional software required.
Qiagen says a second version of the gastrointestinal panel covering five common bacterial pathogens that cause gastrointestinal infections is planned to be submitted to the FDA for clearance in the coming weeks. The company also plans to submit the QIAstat-Dx Rise for FDA clearance early this year.