QIAGEN Gets U.S. Approval for Second QIAstat-Dx Mini GI Panel
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has approved the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, enhancing its syndromic testing portfolio in the United States.This approval builds on the earlier clearance of five panels within the past 10 months for use on the QIAstat-Dx system, further solidifying QIAGEN’s leadership in syndromic testing.
The newly approved QIAstat-Dx Gastrointestinal Panel 2 Mini B is designed specifically for outpatient use and aims to enhance fast and informed treatment decisions by enabling the detection of key bacterial pathogens responsible for gastrointestinal illnesses. This panel focuses on five important bacterial pathogens: Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica. All of these pathogens are recognized by the Infectious Diseases Society of America (IDSA) as major causes of gastrointestinal disease.
This panel complements the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral), which already includes Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Norovirus. Together, these panels provide comprehensive solutions for diagnosing both bacterial and viral causes of gastrointestinal illness, offering healthcare providers the flexibility to tailor testing based on patient needs.
Acute infectious gastroenteritis causes an estimated 179 million cases annually in the U.S., leading to significant outpatient visits and hospitalizations. As a result, the demand for accurate, rapid diagnostics is growing, particularly in outpatient settings. The QIAstat-Dx Gastrointestinal Panel 2 Mini B aims to address this need by enabling quicker diagnoses and more targeted treatments.
Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN, expressed her enthusiasm about the company’s expanded 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,” said Aelbrecht. “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.”
The QIAstat-Dx Gastrointestinal Panel 2 Mini B runs on QIAGEN’s QIAstat-Dx system, which is known for its ability to efficiently multiply numerous genetic targets using real-time PCR technology within the same reaction. This technology delivers results in approximately one hour, with less than one minute of hands-on time. Additionally, the system offers valuable information, including cycle threshold (Ct) values and amplification curves, which help laboratories assess potential co-infections. This data is immediately viewable on the instrument’s touchscreen without the need for additional software, streamlining the diagnostic process.
QIAGEN’s unique position in the market stems from its ability to offer both comprehensive and targeted syndromic gastrointestinal panels. The QIAstat-Dx Gastrointestinal Panel 2 Mini B is specifically optimized for environments where bacterial pathogens are the primary concern, complementing the previously cleared QIAstat-Dx Gastrointestinal Panel 2 Mini B&V panel, which tests for both bacterial and viral pathogens. Together with the FDA-approved 16-target QIAstat-Dx Gastrointestinal Panel 2, which is ideal for hospitalized patients with risk factors for severe disease, QIAGEN offers solutions that cater to both inpatient and outpatient needs.
The QIAstat-Dx system is already available in over 100 countries, with more than 4,600 units deployed worldwide by the end of 2024. Looking ahead, QIAGEN plans to continue expanding its QIAstat-Dx portfolio. The company has recently submitted the QIAstat-Dx Rise, a higher-capacity instrument designed to process up to 160 tests per day, for U.S. regulatory clearance.
QIAGEN’s ability to offer flexible, fast, and efficient diagnostic solutions is becoming increasingly important in the face of rising demand for rapid syndromic testing. Laboratories, healthcare providers, and clinicians now have more options to select tests that meet the specific needs of their patients, improving treatment outcomes and optimizing diagnostic workflows.
About QIAGEN
QIAGEN N.V., based in the Netherlands, is a leading global provider of Sample to Insight solutions. The company enables customers to extract and gain valuable molecular insights from samples containing the building blocks of life. QIAGEN’s technologies isolate and process DNA, RNA, and proteins from blood, tissue, and other materials. Its assay technologies prepare these biomolecules for analysis, while bioinformatics software and knowledge bases interpret the data to find actionable insights. QIAGEN also offers automation solutions that streamline these processes into seamless and cost-effective workflows.
With more than 500,000 customers worldwide, QIAGEN serves the Life Sciences sector (including academia, pharma R&D, and industrial applications such as forensics) and Molecular Diagnostics for clinical healthcare. As of December 31, 2024, the company employed over 5,700 people across more than 35 locations worldwide.
