FDA clears Gastrointestinal (GI) Panels for use on the fully automated QIAstat-Dx Rise platform, marking the ninth U.S. QIAstat-Dx panel clearance in last 24 months
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 N.V. (NYSE:QGEN, Frankfurt Prime Standard: QIA)) today 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.

Expanding menu for the first fully automated syndromic testing platform

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.

"This milestone further strengthens the positioning of QIAstat-Dx Rise as a fully automated platform for syndromic testing in the U.S. 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."

Flexible panel options designed for a seamless testing solution

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. 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.

To learn more, visit https://www.qiagen.com/applications/syndromic-testing.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and Molecular Diagnostics (clinical healthcare). As of December 31, 2025, QIAGEN employed approximately 5,700 people across more than 35 locations. For more information, visit www.qiagen.com.

Forward-Looking Statement

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Source: QIAGEN N.V.

Category: Infectious Diseases

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QIAGEN Receives U.S. Clearance for Gastrointestinal Panels on Fully Automated QIAstat-Dx Rise Syndromic Testing System