QIAGEN secures U.S. clearance for first QIAstat-Dx mini gastrointestinal panel to support year-round outpatient care
QIAGEN announced the U.S. regulatory clearance of the first in a series of QIAstat-Dx Gastrointestinal Panel tests for clinical use.
This clearance by the U.S. Food and Drug Administration (FDA) marks the second mini syndromic panel in the U.S. and made available for use with QIAstat-Dx systems.
The 2025 clearance involves the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (bacterial and viral) covering five causes of gastrointestinal illness that are recommended by the Infectious Diseases Society of America (IDSA): the bacteria Campylobacter, Salmonella, Shiga-like toxin E.Coli (STEC) and Shigella, along with Norovirus, one of the most common causes of gastrointestinal infection and an important target during the winter season.
A second version of the Gastrointestinal Panel covering five common bacterial pathogens that cause gastrointestinal infections (Campylobacter, Salmonella, STEC, Shigella and Yersinia enterocolitica) is also planned to be submitted to the FDA for clearance in the coming weeks.
QIAGEN also plans to submit QIAstat-Dx Rise, a higher-capacity version of the diagnostic instrument, for FDA clearance in early 2025.
This system provides comprehensive testing for up to 160 tests per day using eight Analytical Modules instead of four.
The QIAstat-Dx Gastrointestinal Panel 2 Mini B&V leverages QIAstat-Dx’s ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of co-infections, and are instantly viewable on the instrument touchscreen with no additional software required.
More information on the QIAstat-Dx portfolio can be found here
