Automated Syndromic Testing System Combines Unparalleled Throughput with Simple Workflow

Traditional workflows can bottleneck when volumes surge, delaying targeted therapy. Now, a newly cleared, higher-throughput syndromic system enables rapid, multi-pathogen results at scale, aiming to expand access in the U.S. while maintaining the speed and simplicity required for timely treatment decisions.

QIAGEN (Venlo, Netherlands) has launched QIAstat-Dx Rise – a version of the QIAstat-Dx automated syndromic testing system – in the US. The instrument features automated loading and unloading, priority handling for urgent samples, and eight analytical modules that support 16 batch samples plus two STAT slots per run. Cycle-threshold values and amplification curves are viewable on the touchscreen, delivering actionable detail with minimal hands-on time.

QIAstat-Dx Rise can process up to 160 samples per day, utilizing real-time PCR to detect multiple pathogens from a single specimen and providing results in approximately one hour, with minimal hands-on time required. QIAstat-Dx Rise has received clearance from the U.S. Food and Drug Administration (FDA), making it QIAGEN’s third FDA-cleared QIAstat-Dx product in 2025.

Building on availability in Europe and other regions, the system’s US entry broadens access to rapid respiratory testing now and GI testing next, with additional panels in development. The system targets high-volume hospitals and reference labs, scaling syndromic testing while preserving ease of use to speed clinical decisions. By pairing throughput with accurate, on-instrument insights, the platform is positioned to support surge response and routine diagnostics alike.

“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., empowering labs to automate and scale up testing with minimal hands-on time while delivering the detailed diagnostic insights needed for timely treatment decisions,” said Nadia Aelbrecht, Vice President and Head of Infectious Diseases, QIAGEN, on the system’s U.S. clearance and rollout.