QIAGEN's gastrointestinal panels gain FDA clearance on QIAstat-Dx Rise
QIAGEN has 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.
