QIAGEN Secures FDA Clearance for Full QIAstat-Dx Gastrointestinal Panel Suite on High-Throughput QIAstat-Dx Rise System
QIAGEN N.V., a global leader in molecular diagnostics, announced today a major advancement in its syndromic testing portfolio, as the U.S. Food and Drug Administration (FDA) granted clearance for the complete suite of QIAstat-Dx® Gastrointestinal (GI) Panels for use on the QIAstat-Dx Rise automated high-throughput syndromic testing platform. This approval allows laboratories across the United States to perform both respiratory and gastrointestinal pathogen testing on a single, fully automated system, streamlining laboratory operations and increasing testing efficiency.
Expanding the Capabilities of Automated Syndromic Testing
With the FDA clearance, laboratories can now consolidate their syndromic testing workflows for both respiratory and gastrointestinal pathogens using the QIAstat-Dx Rise platform. Syndromic testing, which allows for simultaneous detection of multiple pathogens associated with similar clinical symptoms, is increasingly critical in modern clinical diagnostics. Traditional testing methods often require separate assays for different pathogens, leading to longer turnaround times and increased workload for laboratory personnel. QIAstat-Dx Rise addresses these challenges by enabling high-throughput, multiplex testing in a single workflow.
The QIAstat-Dx Rise system represents the first fully automated high-throughput solution for syndromic testing from QIAGEN. Introduced to the U.S. market in September 2025, the platform was developed in response to the growing demand for laboratories to process larger volumes of samples while reducing manual intervention. The system’s innovative “smart drawer” design automates cartridge handling, allowing users to load and unload samples with minimal hands-on effort. This design significantly increases walkaway time for laboratory staff, allowing them to focus on other critical tasks.
High Throughput and Rapid Turnaround
The QIAstat-Dx Rise system features up to eight analytical modules capable of processing as many as 160 tests per day. Laboratories can run batches of 16 samples at a time while maintaining dedicated urgent slots for priority testing, ensuring rapid results when immediate clinical decisions are required. The system’s flexibility supports a wide range of clinical scenarios, from routine screening to urgent testing of acutely ill patients.
Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN, emphasized the significance of this milestone: “This FDA clearance further strengthens the positioning of QIAstat-Dx Rise as a fully automated platform for syndromic testing in the U.S. and other countries worldwide. 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.”
Comprehensive and Targeted Testing Options
The FDA clearance encompasses the full range of QIAstat-Dx Gastrointestinal Panels, providing laboratories with flexible options to meet various clinical needs. The QIAstat-Dx Gastrointestinal Panel 2 is a broad panel capable of detecting 16 bacterial, viral, and parasitic pathogens from a single stool sample. This includes clinically relevant Shiga toxin-producing Escherichia coli (STEC) subtypes, such as stx2f, which are important for identifying high-risk infections and guiding appropriate treatment strategies.
In addition to the comprehensive panel, the FDA clearance also includes targeted Mini panels — the QIAstat-Dx GI Panel 2 Mini B and Mini B&V. These panels focus on a smaller subset of pathogens, including STEC, and are designed for specific clinical scenarios where a rapid, focused assessment is preferred. By offering both broad and targeted panels, QIAstat-Dx provides laboratories with the flexibility to tailor testing according to patient needs, laboratory capacity, and workflow requirements.
Fast and Accurate Molecular Detection
The QIAstat-Dx system uses real-time PCR technology to detect pathogen genetic material, delivering results in approximately one hour. This rapid turnaround is particularly valuable in clinical situations where timely decision-making can impact patient outcomes, such as in the case of severe gastrointestinal infections or outbreaks. Despite its high-throughput capabilities, the system requires less than one minute of hands-on time per test, demonstrating its efficiency in laboratory operations.
Results from QIAstat-Dx not only indicate the presence of pathogens but also provide additional molecular insights. The system delivers cycle threshold (Ct) values and amplification curves for each reaction, offering laboratories detailed information that can be critical in cases of co-infection or complex disease presentations. The results are displayed directly on the instrument touchscreen, eliminating the need for separate data analysis software and further simplifying workflow integration.
A Track Record of Regulatory Success
This latest FDA clearance marks the ninth approval for the QIAstat-Dx portfolio within the past 24 months and expands the U.S. portfolio to six cleared panels across the QIAstat-Dx family. It follows the recent FDA authorization of the QIAstat-Dx Rise system for use with QIAstat-Dx Respiratory Panels and the addition of FecalSwab® as a sample type for all QIAstat-Dx Gastrointestinal Panels. These milestones underscore QIAGEN’s ongoing commitment to expanding its molecular diagnostics offerings and improving patient care through innovative, high-quality testing solutions.
Addressing a Global Healthcare Challenge
Respiratory and gastrointestinal infections remain significant contributors to global morbidity and healthcare burden, affecting millions of patients annually. These infections often present with overlapping symptoms, making accurate and rapid pathogen identification essential for effective treatment and infection control. Syndromic testing, as offered by QIAstat-Dx, provides clinicians with a powerful tool to quickly identify the cause of illness and make informed decisions about patient management.
QIAGEN’s QIAstat-Dx systems form part of the company’s broader “Sample to Insight” diagnostic approach, integrating sample preparation, molecular testing, and data interpretation into a seamless workflow. By reducing manual steps, increasing throughput, and providing actionable molecular insights, QIAstat-Dx Rise supports laboratories in delivering timely and accurate results to clinicians and patients.
Global Reach and Impact
Since its launch, QIAstat-Dx has achieved a broad global footprint, with over 5,200 instruments placed in more than 100 countries as of the end of 2025. The QIAstat-Dx Rise system, in particular, is helping laboratories worldwide manage increasing testing demands while maintaining high standards of accuracy and efficiency. With its combination of automation, high throughput, and comprehensive syndromic testing capabilities, QIAstat-Dx Rise is poised to become an essential tool in modern molecular diagnostics, improving patient care and supporting public health efforts globally.
In conclusion, QIAGEN’s FDA clearance of the full QIAstat-Dx Gastrointestinal Panel suite on the QIAstat-Dx Rise platform represents a significant advancement in laboratory diagnostics. By providing high-throughput, fully automated, and flexible testing options, QIAstat-Dx Rise empowers laboratories to consolidate respiratory and gastrointestinal testing, improve turnaround times, and deliver actionable results that support timely and effective patient care. This achievement further solidifies QIAGEN’s leadership in the field of molecular diagnostics and underscores the company’s commitment to enhancing healthcare through innovative technology.