QIAGEN Introduces QIAstat-Dx Rise: A Higher-Throughput Automated Syndromic Testing System Cleared by FDA.

QIAGEN has launched QIAstat-Dx Rise, a higher-throughput version of its automated syndromic testing system, receiving FDA clearance in the US. The system offers increased throughput and ease of use, empowering labs to automate and scale up testing with minimal hands-on time. QIAstat-Dx Rise expands patient access to rapid syndromic testing and builds on the company's commitment to infectious disease diagnostics globally.

QIAGEN N.V. has announced the launch of QIAstat-Dx Rise, a higher-throughput version of its automated syndromic testing system, following FDA clearance in the U.S. The new system, designed to meet the needs of hospitals and reference laboratories, offers unparalleled throughput and ease of use, empowering labs to automate and scale up testing with minimal hands-on time.

QIAstat-Dx Rise can process up to 160 samples per day, with initial launch panels including Respiratory Panel Plus and Respiratory Panel Mini. The system's automated loading and unloading of cartridges, along with priority handling of urgent samples, aims to significantly reduce turnaround time. This marks QIAGEN's third FDA-cleared QIAstat-Dx product in 2025, adding to its growing portfolio of six panels cleared over the last 12 months.

The system is already available in more than 100 countries, with over 4,600 instruments placed globally by the first half of 2025. QIAGEN plans to add gastrointestinal panels to the QIAstat-Dx Rise system in the coming months, further expanding its diagnostic capabilities.

QIAstat-Dx Rise 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 QIAstat-Dx 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. Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of co-infections, instantly viewable on the instrument touchscreen with no additional software required.

This expansion builds on QIAGEN's commitment to infectious disease diagnostics globally, with the company's Sample to Insight solutions serving more than 500,000 customers worldwide in the Life Sciences and Molecular Diagnostics markets.

References:
1. [1] https://www.stocktitan.net/news/QGEN/qiagen-gains-u-s-clearance-of-higher-throughput-qi-astat-dx-rise-ggt46qcx4ogt.html
2. [2] 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