QIAGEN Receives U.S. FDA Clearance for Second QIAstat-Dx Mini Gastrointestinal Panel
QIAGEN has announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its QIAstat-Dx Gastrointestinal Panel 2 Mini B, marking a significant milestone in the company’s commitment to enhancing its syndromic testing portfolio in the United States. This clearance represents QIAGEN’s second FDA approval for a QIAstat-Dx panel in 2025, further bolstering its range of diagnostic solutions aimed at providing targeted, efficient diagnostics for gastrointestinal conditions.
Strengthening QIAGEN’s Syndromic Testing Portfolio
The latest FDA clearance expands QIAGEN’s syndromic testing portfolio, which is designed to address the diagnostic needs of both inpatient and outpatient care. Syndromic testing refers to the use of multiplex panels that detect multiple pathogens from a single patient sample, enabling healthcare providers to make faster and more informed treatment decisions. With this clearance, QIAGEN now offers three mini panels focused on detecting respiratory and gastrointestinal conditions, which are intended for use in outpatient settings.
The QIAstat-Dx Gastrointestinal Panel 2 Mini B is specifically designed to detect bacterial infections that are among the leading causes of gastrointestinal illness. These include Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica. These pathogens are recognized by the Infectious Diseases Society of America (IDSA) as common culprits of gastrointestinal diseases that result in significant outpatient visits and hospitalizations.
Key Features of the QIAstat-Dx Gastrointestinal Panel 2 Mini B
The newly authorized QIAstat-Dx Gastrointestinal Panel 2 Mini B complements QIAGEN’s previously cleared QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral), which includes both bacterial and viral targets, such as Norovirus. The new panel is optimized to focus specifically on bacterial pathogens, offering healthcare providers with a more targeted approach for gastrointestinal diagnostics, particularly in outpatient settings.
The QIAstat-Dx Gastrointestinal Panel 2 Mini B is designed to run on the QIAstat-Dx system, a fully integrated platform that uses real-time PCR technology to quickly detect multiple genetic targets in the same reaction. The system delivers results in about one hour with less than one minute of hands-on time, making it highly efficient for fast-paced clinical environments. The Cycle threshold (Ct) values and amplification curves generated by the system also provide additional valuable insights in cases of co-infections, which can help healthcare providers make more informed clinical decisions.
Addressing the Growing Burden of Gastrointestinal Illness
Acute infectious gastroenteritis leads to an estimated 179 million cases annually in the U.S., making it one of the leading causes of outpatient visits and hospitalizations. The QIAstat-Dx Gastrointestinal Panel 2 Mini B aims to address the urgent need for faster and more accurate diagnostics in the face of this growing healthcare challenge.
With gastrointestinal illnesses causing a substantial burden on healthcare systems, especially in outpatient settings, the QIAstat-Dx system offers an essential tool to streamline diagnostics. Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN, emphasized the importance of expanding the company’s syndromic testing portfolio: “QIAGEN is committed to expanding its syndromic testing portfolio in the U.S. to provide laboratories and clinicians with targeted, efficient diagnostic solutions. With the FDA clearance of our second QIAstat-Dx mini gastrointestinal panel, we are further strengthening our ability to address diverse patient needs while supporting healthcare providers in optimizing diagnostic workflows and offering them the flexibility they need.”
QIAGEN Receives U.S. FDA Clearance for Second QIAstat-Dx Mini Gastrointestinal Panel
Targeted and Comprehensive Gastrointestinal Panels
The newly authorized QIAstat-Dx Gastrointestinal Panel 2 Mini B offers laboratories the flexibility to choose between comprehensive and targeted diagnostic options. QIAGEN is the first company to offer both types of syndromic gastrointestinal panels, making it possible for laboratories to tailor testing to meet specific patient needs. The QIAstat-Dx Gastrointestinal Panel 2 Mini B is optimized for settings where bacterial pathogens are the primary concern, complementing the broader QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, which includes both bacterial and viral targets.
Furthermore, QIAGEN’s FDA-approved 16-target QIAstat-Dx Gastrointestinal Panel 2 is highly suitable for hospitalized patients who are at risk of severe disease, addressing the diagnostic needs of both inpatient and outpatient care. This broad range of testing options is especially important in light of the growing demand for flexible testing that can address healthcare reimbursement challenges while still providing high-quality results in a timely manner.
Expanding the QIAstat-Dx Portfolio
QIAGEN is committed to expanding its QIAstat-Dx portfolio, having already achieved impressive global traction. The QIAstat-Dx system is currently available in more than 100 countries, with over 4,600 instruments placed worldwide through the end of 2024. Looking ahead, QIAGEN plans to further expand its product lineup to support healthcare providers with more diagnostic solutions. This includes the recent submission of the QIAstat-Dx Rise to the U.S. regulatory authorities. The QIAstat-Dx Rise is a higher-capacity instrument designed to process up to 160 tests per day, which will be crucial for high-volume settings and larger healthcare facilities.
Conclusion: Meeting the Demands of Outpatient and Inpatient Care
With the recent FDA clearance of the QIAstat-Dx Gastrointestinal Panel 2 Mini B, QIAGEN has further strengthened its position as a leader in syndromic testing. This new panel complements the company’s existing portfolio, offering targeted and comprehensive diagnostic solutions for gastrointestinal diseases. As the healthcare landscape continues to evolve, the QIAstat-Dx system will play a critical role in providing clinicians and laboratories with fast, efficient, and flexible testing options to support the diagnosis and treatment of gastrointestinal conditions. With a growing number of regulatory clearances and new products in development, QIAGEN is well-positioned to meet the diagnostic needs of healthcare providers and patients worldwide.
More information on the QIAstat-Dx portfolio can be found here: https://www.qiagen.com/product-categories/diagnostics-and-clinical-research/infectious-disease/qiastat-dx-syndromic-testing
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions, enabling customers to extract and gain valuable molecular insights from 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 software and knowledge bases can be used to interpret data to find actionable insights.
Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of December 31, 2024, QIAGEN employed more than 5,700 people in over 35 locations worldwide. For more information, visit www.qiagen.com.
