QIAGEN N.V. announced on September 1, 2025, the U.S. Food and Drug Administration (FDA) clearance of QIAstat-Dx Rise. This higher-throughput version of the QIAstat-Dx automated syndromic testing system offers automated loading and unloading of cartridges, priority handling for urgent samples, and minimal hands-on time.
Designed to meet the needs of hospitals and reference laboratories, QIAstat-Dx Rise significantly increases testing capacity, capable of running up to 160 tests per day across eight analytical modules. This marks QIAGEN’s third FDA-cleared QIAstat-Dx product in 2025, building on a portfolio of six panels cleared over the last 12 months.
The system delivers automated, real-time PCR-based detection of multiple pathogens from a single sample, providing results in about one hour. QIAGEN plans to add its family of gastrointestinal panels to the QIAstat-Dx Rise system in the coming months, further expanding its utility in critical diagnostic settings.
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