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QIAGEN bags FDA nod for full GI testing on QIAstat-Dx Rise system
The approval means US laboratories can now run both respiratory and gastrointestinal panels on the high-throughput QIAstat-Dx Rise
- By IPP Bureau
| March 16, 2026
QIAGEN has announced that the US FDA has cleared all QIAstat-Dx Gastrointestinal (GI) Panels for use on its QIAstat-Dx Rise automated syndromic testing system.
The approval means US laboratories can now run both respiratory and gastrointestinal panels on the high-throughput QIAstat-Dx Rise, consolidating multiple tests on a single platform. The system supports comprehensive syndromic panels that detect multiple pathogens in one test, alongside targeted Mini panels focused on select pathogens.
Launched in the US in September 2025, QIAstat-Dx Rise was designed to meet the growing demand for higher testing capacity and automation in molecular diagnostics labs. Its smart drawer design automates cartridge loading and unloading, reducing manual handling and increasing walkaway time.
With up to eight analytical modules, the Rise system can process up to 160 tests per day, running 16 samples per batch while keeping slots open for urgent testing.
“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.”
