QIAGEN has received U.S. FDA clearance for its QIAstat-Dx Rise system, a higher-throughput version of its syndromic testing platform designed to process up to 160 samples per day with minimal hands-on time. The clearance opens the door for expanded patient access to fast, accurate infectious disease diagnostics across U.S. hospitals and reference labs.
The new system automates cartridge loading and unloading, enables priority handling of urgent samples, and delivers results in about one hour. With eight analytical modules, QIAstat-Dx Rise can handle up to 16 batch samples plus two urgent slots per run, helping laboratories manage both routine testing and time-sensitive cases efficiently.
“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.,” said Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN. “This system empowers labs to automate and scale up testing with minimal hands-on time while still delivering the detailed diagnostic insights needed for timely treatment decisions.”
Expanding a Proven Platform
This clearance marks QIAGEN’s third FDA-cleared QIAstat-Dx product in 2025, following a wave of recent panel authorizations. More than 4,600 QIAstat-Dx instruments are already placed worldwide, with adoption in over 100 countries.
The initial U.S. launch of QIAstat-Dx Rise will include the Respiratory Panel Plus and Respiratory Panel Mini, with additional panels—including the Gastrointestinal Panel 2, Gastrointestinal Mini B&V, and Gastrointestinal Panel Mini B—planned for future release. QIAGEN is also developing further panels to expand both the standard QIAstat-Dx and QIAstat-Dx Rise menus.
Technology and Impact
QIAstat-Dx systems use real-time PCR technology to simultaneously detect multiple pathogens from a single patient sample. Cycle threshold (Ct) values and amplification curves are viewable directly on the instrument touchscreen, providing clinicians with deeper diagnostic insights without additional software.
By combining high throughput, automated workflows, and rapid turnaround times, QIAstat-Dx Rise is designed to help healthcare providers respond more effectively to infectious disease outbreaks, manage co-infections, and streamline lab operations.
For more information on QIAstat-Dx Rise and the full portfolio of syndromic testing solutions, visit QIAGEN’s syndromic testing page.
