QIAGEN receives U.S. clearance for second QIAstat-Dx mini gastrointestinal panel, expanding U.S. syndromic testing portfolio

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, further strengthening its syndromic testing portfolio in the United States.

This marks QIAGEN’s second FDA clearance of a QIAstat-Dx panel in 2025, and builds on the authorization of five panels for use on the QIAstat-Dx system within the last 10 months.

QIAGEN has now received regulatory clearances for three mini panels for detection of respiratory and gastrointestinal conditions, with these panels designed for outpatient use to aid fast and informed treatment decisions.

This newly authorized panel focuses solely on bacterial infections covering Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica – all recognized by the Infectious Diseases Society of America (IDSA) as leading causes of gastrointestinal illness. It is designed to complement the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral) that covers Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Norovirus.

Acute infectious gastroenteritis leads to an estimated 179 million cases annually in the U.S., driving significant numbers of outpatient visits and hospitalizations.¹

“QIAGEN is committed to expanding its syndromic testing portfolio in the U.S. to provide laboratories and clinicians with targeted, efficient diagnostic solutions,” said Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN. “With the FDA clearance of our second QIAstat-Dx mini gastrointestinal panel, we are further strengthening our ability to address diverse patient needs while supporting healthcare providers in optimizing diagnostic workflows and offering them the flexibility they need.”

The QIAstat-Dx Gastrointestinal Panel 2 Mini B runs on QIAGEN’s QIAstat-Dx system and leverages its 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.