• 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. 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. The regulatory milestone expands the capabilities of QIAGEN’s molecular diagnostics platform and strengthens its role in advancing rapid, automated infectious disease detection across clinical laboratories.

With this clearance, laboratories can now run both QIAstat-Dx Respiratory Panels and QIAstat-Dx Gastrointestinal Panels on the high-throughput QIAstat-Dx Rise platform. The system is designed to support comprehensive syndromic testing, allowing clinicians to detect multiple pathogens associated with similar symptoms through a single diagnostic test. In addition to full panels, laboratories can also use targeted Mini panels that focus on specific groups of pathogens, improving diagnostic flexibility and operational efficiency.

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QIAGEN launched the QIAstat-Dx Rise system in the United States in September 2025 to address the increasing demand for higher testing capacity and automation in molecular diagnostics laboratories. The system features a smart drawer design that automates cartridge loading and unloading, helping reduce manual handling while increasing laboratory walkaway time.

The high-throughput platform can operate with up to eight analytical modules and process as many as 160 tests per day. Laboratories can run batches of up to 16 samples while maintaining dedicated urgent slots for priority testing, enabling faster turnaround when clinicians require immediate diagnostic insights to guide treatment decisions.

Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN, stated, “This milestone further strengthens the positioning of QIAstat-Dx Rise as a fully automated platform for syndromic testing.” She pointed out that the ability to combine gastrointestinal and respiratory tests on a single system facilitates laboratory operations while offering the precise molecular insights required for prompt patient care.

The QIAstat-Dx Gastrointestinal Panel 2, which can identify 16 bacterial, viral, and parasite pathogens from a single stool sample – including clinically relevant Shiga toxin-producing E. coli (STEC) subtypes like stx2f – is part of the FDA clearance. The QIAstat-Dx GI Panel 2 Mini B and Mini B&V, which offer targeted detection of five important gastrointestinal pathogens, including STEC, are also included.

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Using real-time PCR technology, the system delivers results in approximately one hour while requiring less than one minute of hands-on time per test. The platform also provides cycle threshold (Ct) values and amplification curves within the same reaction, offering additional diagnostic context in cases of co-infection. Results are displayed directly on the instrument’s touchscreen, eliminating the need for additional software.

This clearance represents the ninth FDA approval for the QIAstat-Dx portfolio within the past 24 months, expanding the U.S. portfolio to six panels cleared for the QIAstat-Dx system family. It also follows recent FDA authorization of the QIAstat-Dx Rise platform for use with respiratory testing panels and the addition of the FecalSwab® sample type across gastrointestinal panels.

Respiratory and gastrointestinal infections affect millions of patients globally each year, placing significant strain on healthcare systems. Syndromic testing platforms like QIAstat-Dx enable clinicians to quickly identify infectious causes and implement appropriate treatment and infection control measures. Currently available in more than 100 countries, the QIAstat-Dx platform has seen more than 5,200 instruments installed worldwide as of the end of 2025, reinforcing its role in modern molecular diagnostics workflows.

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