QIAGEN Receives U.S. Clearance for Gastrointestinal Panels on Fully Automated QIAstat-Dx Rise Syndromic Testing System

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

Mar. 11, 2026 at 4:37am

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QIAGEN N.V. 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 now run both QIAstat-Dx Respiratory and QIAstat-Dx GI panels on QIAstat-Dx Rise, the high-throughput version of the QIAstat-Dx system.

Why it matters

Expanding the menu for the first fully automated syndromic testing platform, this clearance further strengthens the positioning of QIAstat-Dx Rise as a comprehensive solution for molecular diagnostics laboratories. Consolidating respiratory and gastrointestinal testing on one system can help streamline operations and support timely treatment decisions.

The details

The FDA clearance includes the QIAstat-Dx Gastrointestinal Panel 2, detecting 16 bacterial, viral and parasitic pathogens from a single stool sample, as well as the QIAstat-Dx GI Panel 2 Mini B and Mini B&V, providing targeted detection of five gastrointestinal pathogens. Results are delivered in about one hour using real-time PCR technology, with less than one minute of hands-on time per test.

  • QIAGEN launched QIAstat-Dx Rise in the U.S. in September 2025.
  • This U.S. regulatory clearance represents the ninth FDA clearance for the QIAstat-Dx portfolio in the past 24 months.

The players

QIAGEN N.V.

A global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples.

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of food, drugs, and other products in the United States.

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What they’re saying

“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.”

— Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN

The takeaway

This FDA clearance expands the menu of the QIAstat-Dx Rise platform, allowing laboratories to consolidate respiratory and gastrointestinal testing on a single automated system. This can help streamline operations and support timely clinical decision-making, further strengthening QIAGEN's position in the syndromic testing market.