Originally published by our sister publication Infectious Disease Special Edition
The FDA cleared Qiagen’s 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.
This newly cleared 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 GI illness. It is designed to complement the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral) panel that covers Campylobacter, Salmonella, STEC, Shigella and norovirus.
Acute infectious gastroenteritis leads to an estimated 179 million cases annually in the United States, driving significant numbers of outpatient visits and hospitalizations (Am J Gastroenterol 2023;118[6]:1069-1079).
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 polymerase chain reaction technology in the same reaction, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold values and amplification curves provide laboratories with additional information in the context of coinfections, and are instantly viewable on the instrument touchscreen with no additional software required.
Qiagen now offers both comprehensive and targeted syndromic GI panels, allowing laboratories to tailor testing to their specific requirements. The QIAstat-Dx Gastrointestinal Panel 2 Mini B is optimized for settings where bacterial pathogens are the primary concern, complementing the previously cleared QIAstat-Dx Gastrointestinal Panel 2 Mini B&V panel, which includes both bacterial and viral targets.
“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, the 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.”
More information on the QIAstat-Dx portfolio can be found here.