QIAGEN N.V. Launches QIAstat-Dx Rise, a High-Throughput Automated Syndromic Testing System with FDA Clearance.

QIAGEN N.V. has received FDA clearance for QIAstat-Dx Rise, a higher-throughput version of its automated syndromic testing system. The new system offers unparalleled throughput with a simplified workflow, meeting the needs of hospitals and reference laboratories seeking rapid testing with minimal hands-on time. Already available in over 100 countries, QIAstat-Dx Rise can run up to 160 tests per day and delivers results in about one hour. QIAGEN plans to add gastrointestinal panels to the system in the coming months.

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) has announced the FDA clearance of QIAstat-Dx Rise, a higher-throughput version of its automated syndromic testing system. The new system, designed to meet the needs of hospitals and reference laboratories, offers unparalleled throughput with a simplified workflow, enabling rapid testing with minimal hands-on time.

QIAstat-Dx Rise can process up to 160 samples per day, utilizing eight analytical modules, including 16 batch samples and two urgent slots per run. The system delivers results in about one hour, significantly increasing testing capacity while maintaining the speed and ease of use that QIAstat-Dx is known for. The first two panels for respiratory conditions are already available, with additional gastrointestinal panels, such as the QIAstat-Dx Gastrointestinal Panel 2, QIAstat-Dx Gastrointestinal Mini B&V, and QIAstat-Dx Gastrointestinal Panel Mini B, planned for the coming months [1].

The system offers automated, real-time PCR-based detection of multiple pathogens from a single sample. Cycle threshold (Ct) values and amplification curves are instantly viewable on the instrument touchscreen, providing laboratories with additional information in the context of co-infections without the need for additional software. This clearance marks QIAGEN’s third FDA-cleared QIAstat-Dx product in 2025, adding to its growing portfolio of six panels cleared for the QIAstat-Dx family over the last 12 months [2].

As of June 30, 2025, QIAstat-Dx Rise is already available in more than 100 countries, with over 4,600 instruments placed globally through the first half of 2025. The 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 [1].

References:

[1] https://www.businesswire.com/news/home/20250901414875/en/QIAGEN-Gains-U.S.-Clearance-of-Higher-Throughput-QIAstat-Dx-Rise-Expanding-Patient-Access-to-Rapid-Syndromic-Testing

[2] https://www.barchart.com/story/news/34528167/qiagen-gains-u-s-clearance-of-higher-throughput-qiastat-dx-rise-expanding-patient-access-to-rapid-syndromic-testing