US FDA Clears Qiagen's Syndromic Testing System

Qiagen NV, a Netherlands-based holding company, has announced that its US FDA has cleared a syndromic testing system. Qiagen provides Sample to Insight solutions that integrate sample and assay technologies, bioinformatics, and automation systems to transform biological samples into molecular insights. The company's automation platforms tie these together in molecular testing workflows from Sample to Insight.

QIAGEN NV, a leading global provider of Sample to Insight solutions, has received U.S. Food and Drug Administration (FDA) clearance for its QIAstat-Dx Rise system. This high-throughput syndromic testing system is designed to meet the needs of hospitals and reference laboratories seeking highly automated diagnostic testing with minimal hands-on time.

The QIAstat-Dx Rise system can process up to 160 samples per day, significantly increasing testing capacity. It offers automated, real-time PCR-based detection of multiple pathogens from a single sample, delivering results in about one hour with less than one minute of hands-on time. The system includes initial panels for respiratory conditions and plans to add gastrointestinal panels in the coming months.

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 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 instruments in the U.S. aligns with QIAGEN's global strategy to enhance access to infectious disease diagnostics. The company's automation platforms integrate sample and assay technologies, bioinformatics, and automation systems to transform biological samples into molecular insights.

QIAGEN's strong customer response to the lower-throughput version of the QIAstat-Dx system has empowered labs to automate and scale up testing. The new QIAstat-Dx Rise system builds on this success, offering higher throughput and ease of use.

[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