FDA Clears Higher-Throughput Syndromic Testing Tool From QIAGEN

QIAGEN N.V. has launched QIAstat‑Dx Rise, a version of the QIAstat-Dx automated syndromic testing system that offers unparalleled throughput with an easy workflow.

The new U.S. Food and Drug Administration (FDA)-cleared system is designed to meet the needs of hospitals and reference laboratories seeking highly automated syndromic testing with automated cartridge loading and unloading, access to priority handling of urgent samples, and 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.”

The FDA clearance marks QIAGEN’s third authorized QIAstat-Dx product this year, and builds on a growing portfolio of six panels cleared for the QIAstat-Dx family over the last 12 months. The system is 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 currently available. In the next several months, QIAGEN also plans to add to the QIAstat-Dx Rise system 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 both speed and ease of use. 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.

A Netherlands-based holding company, QIAGEN N.V. is a leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing life’s building blocks. The company’s Sample technologies isolate and process DNA, RNA, and proteins from blood, tissue, and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support complex data interpretation to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the life sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and molecular diagnostics (clinical healthcare). As of June 30, 2025, QIAGEN employed approximately 5,700 workers in more than 35 locations.