QIAGEN Gains FDA Approval for New QIAstat-Dx Gastrointestinal Panel 2 Mini B, Expanding Syndromic Testing Options

QIAGEN Gains FDA Approval for New QIAstat-Dx Gastrointestinal Panel 2 Mini B, Expanding Syndromic Testing Options

(IN BRIEF) QIAGEN has received FDA approval for its QIAstat-Dx Gastrointestinal Panel 2 Mini B, expanding its syndromic testing offerings for gastrointestinal infections in the U.S. This new panel targets five major bacterial pathogens and complements the previously cleared QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, which detects both bacterial and viral pathogens. The FDA approval strengthens QIAGEN’s portfolio, with the company having secured six clearances in the past 10 months. The QIAstat-Dx system delivers fast, real-time PCR-based results, enhancing treatment decisions for clinicians and improving patient care.

(PRESS RELEASE) VENLO, 7-Mar-2025 — /EuropaWire/ — QIAGEN has announced the FDA clearance of its new QIAstat-Dx Gastrointestinal Panel 2 Mini B, expanding its range of syndromic testing solutions for gastrointestinal infections in the United States. This marks the company’s second FDA approval for a QIAstat-Dx panel in 2025, continuing its momentum in the U.S. market, with six regulatory clearances for QIAstat-Dx panels received in just the past 10 months.

The newly approved panel, designed specifically for outpatient use, focuses on five key bacterial pathogens that are commonly associated with gastrointestinal illnesses: Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica. These bacteria are identified by the Infectious Diseases Society of America (IDSA) as significant contributors to gastrointestinal infections in the U.S. The QIAstat-Dx Gastrointestinal Panel 2 Mini B will complement the previously cleared QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, which detects both bacterial and viral pathogens, including Norovirus.

This development comes at a time when acute infectious gastroenteritis is responsible for an estimated 179 million cases annually in the U.S., leading to numerous outpatient visits and hospitalizations. By enabling rapid detection of these pathogens, QIAGEN’s panels support faster, more informed treatment decisions, ultimately benefiting both clinicians and patients.

“QIAGEN is dedicated to enhancing its syndromic testing portfolio in the U.S. to offer laboratories and healthcare providers advanced, efficient diagnostic tools,” said Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN. “With the FDA approval of our second QIAstat-Dx mini gastrointestinal panel, we are strengthening our ability to meet diverse clinical needs and improve diagnostic workflows while providing flexibility for healthcare providers.”

The QIAstat-Dx Gastrointestinal Panel 2 Mini B is powered by QIAGEN’s QIAstat-Dx system, which uses real-time PCR technology to detect multiple genetic targets in a single test, providing results in approximately one hour with minimal hands-on time. The system offers real-time data on cycle threshold values and amplification curves, helping laboratories identify co-infections and gain deeper insights into their results.

As the first company to offer both comprehensive and targeted syndromic gastrointestinal panels, QIAGEN provides laboratories with the flexibility to tailor their testing approach. The QIAstat-Dx Gastrointestinal Panel 2 Mini B is particularly suited for environments where bacterial pathogens are of primary concern, complementing the more comprehensive QIAstat-Dx Gastrointestinal Panel 2 Mini B&V that includes both bacterial and viral targets.

With more than 4,600 QIAstat-Dx instruments in use globally, QIAGEN continues to expand its diagnostic solutions and has recently submitted the higher-capacity QIAstat-Dx Rise for U.S. regulatory clearance, designed to process up to 160 tests per day.

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.

Forward-Looking Statement

Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN’s products, development timelines, marketing and / or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results – such as expected adjusted net sales and adjusted diluted earnings – are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, regulatory processes and logistical dependencies), variability in operating results and allocations between customer classes, commercial development for our products to customers in the Life Sciences and clinical healthcare, changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancements; fluctuating demand for QIAGEN’s products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN’s products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other “force majeure” events. There is also no guarantee that anticipated benefits from acquisitions will materialize as expected. For a comprehensive overview of risks, please refer to the “Risk Factors” contained in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission.

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1 Moon RC, Bleak TC, Rosenthal NA, et al. Epidemiology and Economic Burden of Acute Infectious Gastroenteritis Among Adults Treated in Outpatient Settings in US Health Systems [published online ahead of print, 2023 Feb 3]. Am J Gastroenterol. 2023;10.14309/ajg.0000000000002186. doi:10.14309/ajg.0000000000002186

Media Contacts:

Dr. Thomas Theuringer
Senior Director Corporate Communications & Head Of External Communications
Germany: +49 2103 29 11826
Mobile: +49 1520 18 11826
thomas.theuringer@qiagen.com

Lisa Specht
Manager Public Relations
Germany: +49 2103 29 14181
Mobile: +49 152 01811381
lisa.specht@qiagen.com

SOURCE: QIAGEN

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