• 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

Company Website: https://corporate.qiagen.com/newsroom/press-releases
GERMANTOWN, Md. & VENLO, Netherlands -- (Business Wire)

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

Certain statements contained in this release may be considered 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 can be identified by the use of forward-looking terminology such as “believe”, “hope”, “plan”, “intend”, “seek”, “may”, “will”, “could”, “should”, “would”, “expect”, “anticipate”, “estimate”, “continue”, “target” or other similar words. To the extent that any of the statements contained herein relating to QIAGEN’s products, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, acquisitions, collaborations, markets, strategy or operating results, including without limitation its expected net sales, net sales of particular products, net sales in particular geographies, adjusted net sales, expansion of adjusted operating income margin, returns to shareholders, progressive dividend payments, product portfolio management, product launches (including anticipated launches of our sequencing solutions, testing platforms, panels and systems), leveraging AI technology, improvements in operating and financial leverage, currency movements against the U.S. dollar, plans for investment in our portfolio and share repurchase commitments, our expectations relating to our adjusted tax rate, debt maturity and repayment, our ability to grow adjusted earnings per share at a greater rate than sales, our ability to improve operating efficiencies and maintain disciplined capital allocation, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with our dependence on the development and success of new products; management of growth and expansion of operations (including the effects of currency fluctuations, tariffs, tax laws, regulatory processes and logistics and supply chain dependencies); variability of operating results; integration of acquired businesses; changes in relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors, including delays or limits in the amount of reimbursement approvals or public health funding); our ability to obtain and maintain product regulatory approvals; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, including inflation and changing interest rates, weather or transportation delays, natural disasters, cyber security breaches, political or public health crises, and the resulting impact on the demand for our products and other aspects of our business, or other force majeure events; litigation risk, including patent litigation and product liability; debt service obligations; volatility in the public trading price of our common shares; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” in our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.

Category: Infectious Diseases

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Contacts:

QIAGEN contacts:
Public Relations
e-mail: pr@QIAGEN.com

Investor Relations
e-mail: ir@QIAGEN.com

Source: QIAGEN N.V.