Qiagen N.V. announced that the U.S. Food and Drug Administration cleared all of its QIAstat‑Dx gastrointestinal panels for use on the QIAstat‑Dx Rise automated syndromic testing system on March 10, 2026.
The clearance allows laboratories to run both respiratory and gastrointestinal panels on a single high‑throughput instrument that can process up to 160 tests per day, features automated cartridge loading and unloading, minimal hands‑on time, and the ability to prioritize urgent samples.
By adding the gastrointestinal menu, Qiagen expands the Rise platform’s portfolio to nine U.S. panels in the last 24 months, reinforcing its strategy to consolidate testing capabilities and drive recurring consumable sales across its flagship syndromic testing line.
"The launch of QIAstat‑Dx Rise marks a significant step forward in our commitment to expand access to infectious disease diagnostics across the U.S., and builds on the expansion efforts for this system in other areas of the world," said Nadia Aelbrecht, Vice President and Head of Infectious Diseases at Qiagen.
Qiagen’s syndromic testing systems are installed in more than 5,200 instruments worldwide and serve over 100 countries, positioning the company to capture growing demand for rapid, multiplex diagnostics in both clinical and public health settings.
The gastrointestinal clearance gives Qiagen a competitive edge over other syndromic testing providers by offering a higher‑throughput, fully automated platform that reduces labor costs and turnaround time, thereby enhancing laboratory efficiency and supporting antimicrobial stewardship efforts.
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