
GERMANTOWN, Md., & VENLO, The Netherlands–(BUSINESS WIRE)–QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today 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, supporting QIAGEN’s strategy to improve patient treatment options in this important market.
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.