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Qiagen N.V. announced that the US 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, marking the ninth US QIAstat-Dx Panel clearance in last 24 months.
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.
Laboratories can now run respiratory and gastrointestinal panels, including comprehensive and Mini panels, on one scalable automated system. QIAstat-Dx Rise delivers higher-throughput automation for up to 160 tests per day with minimal hands-on time while supporting urgent sample prioritization.
Qiagen launched QIAstat-Dx Rise in the US 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.
“This milestone further strengthens the positioning of QIAstat-Dx Rise as a fully automated platform for syndromic testing in the US and other countries around the world,” said Nadia Aelbrecht, vice president and head of infectious diseases at Qiagen. “Laboratories can now consolidate respiratory and gastrointestinal testing on one system. By combining scalable automation with detailed molecular insights, QIAstat-Dx systems can help laboratories streamline operations while supporting timely treatment decisions.”
The US 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 US regulatory clearance represents the ninth US FDA clearance for the QIAstat-Dx portfolio in the past 24 months and expands the US 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. Qiagen’s 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.
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