Gastrointestinal Panel Delivers Rapid Detection of Five Common Bacterial Pathogens for Outpatient Use

Acute infectious gastroenteritis results in approximately 179 million cases each year in the United States, leading to a significant number of outpatient visits and hospitalizations. To address this, a new gastrointestinal panel offers rapid detection of five common bacterial pathogens for outpatient use, enabling faster and more informed treatment decisions.

QIAGEN’s (Venlo, The Netherlands) QIAstat-Dx Gastrointestinal Panel 2 Mini B has been cleared by the U.S. Food and Drug Administration (FDA) for clinical use, enhancing the company’s syndromic testing offerings in the U.S. market. This newly approved panel focuses specifically on bacterial infections, detecting Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica—pathogens identified by the Infectious Diseases Society of America (IDSA) as major causes of gastrointestinal illnesses. The panel complements the existing QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral), which includes these same bacterial pathogens and also adds Norovirus.

The QIAstat-Dx Gastrointestinal Panel 2 Mini B operates on the QIAstat-Dx system, utilizing real-time PCR technology to rapidly amplify multiple genetic targets in a single reaction. Results are delivered in approximately one hour, with less than one minute of hands-on time required. Cycle threshold (Ct) values and amplification curves offer additional insights into co-infections, all of which are immediately visible on the instrument’s touchscreen without needing any additional software. The QIAstat-Dx system is available in over 100 countries, with more than 4,600 instruments installed globally by the end of 2024.

This marks the second FDA clearance for a QIAstat-Dx panel in 2025, following the approval of five panels for use on the QIAstat-Dx system over the past 10 months. QIAGEN has now received regulatory clearance for three mini panels designed for outpatient use, which assist in providing fast and accurate treatment decisions for both respiratory and gastrointestinal conditions. The QIAstat-Dx Gastrointestinal Panel 2 Mini B is specifically optimized for settings where bacterial pathogens are the primary concern, offering a complement to the previously cleared QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, which covers both bacterial and viral targets.

QIAGEN is the first company to provide both comprehensive and targeted syndromic gastrointestinal panels, enabling laboratories to customize testing to meet their specific needs. In addition to the newly cleared panels, the FDA-approved 16-target QIAstat-Dx Gastrointestinal Panel 2 is ideal for hospitalized patients with higher risk factors for severe disease. These panels address the unique diagnostic needs of both inpatient and outpatient care, responding to the increasing demand for flexible testing options to manage healthcare reimbursement challenges. QIAGEN also plans to expand its QIAstat-Dx portfolio and has recently submitted the QIAstat-Dx Rise, a high-capacity instrument capable of processing up to 160 tests per day, for U.S. regulatory approval.

“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.”