QIAGEN Gains U.S. Clearance of Higher-Throughput QIAstat-Dx Rise, Expanding Patient Access to Rapid Syndromic Testing

Original from: QIAGEN

· U.S. market entry set to begin for QIAstat-Dx Rise – a version of QIAstat-Dx for syndromic testing that combines unparalleled throughput with the easiest workflow

· QIAstat-Dx Rise launch can process up to 160 samples per day, initial launch includes Respiratory Panel Plus and Respiratory Panel Mini and additional panels in development

· Expansion of QIAstat-Dx instrument portfolio in the U.S. builds on the availability of both system options in Europe and other regions of the world

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of QIAstat‑Dx Rise – a version of the QIAstat-Dx automated syndromic testing system that offers unparalled throughput with the easiest workflow available to customers worldwide.

The new system, which received clearance from the U.S. Food and Drug Administration (FDA), is designed to meet the needs of hospitals and reference laboratories seeking highly automated syndromic testing with automated loading and unloading of cartridges, access to priority handling of urgent samples and only a minimum of hands-on time.

“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. “QIAstat-Dx builds on the strong customer response to the lower-throughput version, empowering labs to automate and scale up testing with minimal hands-on time while delivering the detailed diagnostic insights needed for timely treatment decisions.”

This clearance marks QIAGEN’s third FDA-cleared QIAstat-Dx product in 2025, and builds on a growing portfolio of six panels cleared for the QIAstat-Dx family over the last 12 months. The system is already available in more than 100 countries, with over 4,600 instruments placed globally through the first half of 2025.

The first two panels for respiratory conditions are already available. QIAGEN also plans to add to the QIAstat-Dx Rise system in the coming months its family of gastrointestinal panels including the QIAstat-Dx Gastrointestinal Panel 2, QIAstat-Dx Gastrointestinal Mini B&V and QIAstat-Dx Gastrointestinal Panel Mini B. Additional panels for both QIAstat-Dx and QIAstat-Dx Rise are in development.

QIAstat-Dx Rise delivers automated, real-time PCR-based detection of multiple pathogens from a single sample, significantly increasing testing capacity while maintaining the speed and ease of use that QIAstatDx is known for. With the ability to run up to 160 tests per day across eight analytical modules – including 16 batch samples and two urgent slots per run – the system enables fast and accurate diagnoses in settings where turnaround time is critical.

QIAstat-Dx quickly multiplies many genetic targets using real-time PCR technology in the same reaction, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of co-infections, and are instantly viewable on the instrument touchscreen with no additional software required.

Source: QIAGEN Gains U.S. Clearance of Higher-Throughput QIAstat-Dx Rise, Expanding Patient Access to Rapid Syndromic Testing