QIAGEN Receives FDA Clearance for High-Throughput QIAstat-Dx Rise Syndromic Testing System
Key Insights
QIAGEN launched QIAstat-Dx Rise (search), a high-throughput version of its automated syndromic testing system that received FDA clearance and can process up to 160 samples per day.
The system offers automated loading and unloading of cartridges with minimal hands-on time, designed for hospitals and reference laboratories requiring rapid infectious disease (search) diagnostics.
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.
QIAGEN N.V. announced the launch of QIAstat-Dx Rise (search), a high-throughput version of its automated syndromic testing system that has received clearance from the U.S. Food and Drug Administration. The system represents a significant advancement in infectious disease (search) diagnostics, offering unparalleled throughput combined with streamlined workflow automation for hospitals and reference laboratories.
Enhanced Testing Capacity and Automation
QIAstat-Dx Rise (search) 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 the QIAstat-Dx platform is known for. The system can run up to 160 tests per day across eight analytical modules, including 16 batch samples and two urgent slots per run, enabling fast and accurate diagnoses in settings where turnaround time is critical.
The system features automated loading and unloading of cartridges, access to priority handling of urgent samples, and requires only minimal hands-on time. QIAstat-Dx quickly multiplies many genetic targets using real-time PCR technology in the same reaction, delivering results in about one hour with less than one minute of hands-on time.
Clinical Utility and Technical Features
Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of co-infections (search), and are instantly viewable on the instrument touchscreen with no additional software required. This technical capability enhances the diagnostic value for clinicians making treatment decisions.
"The launch of QIAstat-Dx Rise (search) marks a significant step forward in our commitment to expand access to infectious disease (search) 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."
Regulatory Milestones and Market Presence
This clearance marks QIAGEN's third FDA-cleared QIAstat-Dx product in 2025, building on a growing portfolio of six panels cleared for the QIAstat-Dx family over the last 12 months. The system demonstrates the company's continued expansion in the U.S. molecular diagnostics market.
The QIAstat-Dx platform is already available in more than 100 countries, with over 4,600 instruments placed globally through the first half of 2025, indicating strong international adoption of the technology.
Available Testing Panels and Future Development
The first two panels for respiratory conditions (search) are already available for the QIAstat-Dx Rise (search) system. QIAGEN plans to add its family of gastrointestinal (search) panels in the coming months, 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 currently in development, expanding the diagnostic capabilities of the platform.