QIAGEN Wins FDA Clearance for QIAstat-Dx Rise, Expanding U.S. Syndromic Testing Capabilities

QIAGEN announced FDA clearance and U.S. launch of its QIAstat-Dx Rise, an expanded version of its syndromic testing system designed to meet the demands of hospitals and reference labs. The platform automates cartridge loading and unloading, allows priority handling of urgent samples, and reduces hands-on time to under a minute per test. With eight analytical modules, the system can process up to 160 tests per day while delivering results in about one hour.

The first panels available include the Respiratory Panel Plus and Respiratory Panel Mini, with gastrointestinal panels expected later this year. QIAstat-Dx Rise builds on the success of QIAstat-Dx, which has already been placed in more than 4,600 sites across over 100 countries. The company has received three FDA clearances for QIAstat-Dx products in 2025 alone, expanding its menu to six panels over the past year.

QIAstat-Dx uses real-time PCR to detect multiple pathogens simultaneously, offering clinicians cycle threshold values and amplification curves to aid in interpreting co-infections. These features are available directly on the system’s touchscreen, with no additional software required. The U.S. introduction of QIAstat-Dx Rise aligns with QIAGEN’s strategy to scale up infectious disease diagnostics globally.