QIAGEN N.V. announced that the U.S. Food and Drug Administration (FDA) has cleared the use of all QIAstat-Dx Gastrointestinal (GI) Panels on the QIAstat-Dx Rise automated syndromic testing system. With this milestone, laboratories can run both QIAstat-Dx Respiratory and QIAstat-Dx GI panels on QIAstat-Dx Rise, the high-throughput version of the QIAstat-Dx system. Both versions support comprehensive syndromic testing with panels designed to detect multiple pathogens associated with similar symptoms in a single test, as well as targeted Mini panels that focus on a defined group of pathogens.
QIAGEN launched QIAstat-Dx Rise in the U.S. in September 2025 to address growing demand for higher testing capacity and increased automation in molecular diagnostics laboratories. The system features a smart drawer design that automates cartridge loading and unloading, helping users reduce manual handling and increase walkaway time. With up to eight analytical modules, QIAstat-Dx Rise can process up to 160 tests per day.
Laboratories can run 16 samples in a batch while maintaining dedicated urgent slots for priority samples, supporting fast turnaround times when timely clinical decisions are required. The FDA clearance includes QIAstat-Dx Gastrointestinal Panel 2, detecting 16 bacterial, viral and parasitic pathogens from a single stool sample (Para-Pak C&S or FecalSwab), including clinically relevant Shiga toxin-producing E. coli (STEC) subtypes such as stx2f. QIAstat-Dx GI Panel 2 Mini B and Mini B&V, providing targeted detection of five gastrointestinal pathogens, including STEC.
Results are delivered in about one hour using real-time PCR technology, which detects genetic material from pathogens. The system requires less than one minute of hands-on time per test. QIAstat-Dx provides cycle threshold (Ct) values and amplification curves in the same reaction, giving laboratories additional context in cases of co-infection.
Results are displayed directly on the instrument touchscreen without requiring additional software. This U.S. regulatory clearance represents the ninth FDA clearance for the QIAstat-Dx portfolio in the past 24 months and expands the U.S. portfolio to six panels cleared for the QIAstat-Dx family. It also follows the recent FDA authorization of QIAstat-Dx Rise for use with QIAstat-Dx Respiratory Panels and the addition of the FecalSwab sample type across all QIAstat-Dx Gastrointestinal Panels.
Respiratory and gastrointestinal infections affect millions of patients worldwide each year and place a significant burden on healthcare systems. Syndromic testing helps clinicians identify the cause of infection in patients with similar symptoms, supporting appropriate treatment and infection control decisions. QIAstat-Dx portfolio is part of the company?s broader Sample to Insight offering, which integrates sample preparation, molecular testing and data interpretation into streamlined diagnostic workflows. The QIAstat-Dx systems are available in more than 100 countries, with more than 5,200 instruments placed worldwide since launch as of the end of 2025.
