Qiagen Gains US Clearance for Higher-Throughput QIAstat-Dx Rise

Qiagen NV has gained US clearance for its QIAstat-Dx Rise, a higher-throughput diagnostic test. The test integrates sample and assay technologies, bioinformatics, and automation systems to analyze biomolecules and provide actionable insights. Qiagen's Sample to Insight solutions transform biological samples into molecular insights, making biomolecules visible for analysis.

QIAGEN NV (NYSE: QGEN) has secured U.S. Food and Drug Administration (FDA) clearance for its QIAstat-Dx Rise, a higher-throughput diagnostic test system designed to meet the needs of hospitals and reference laboratories. The QIAstat-Dx Rise system offers unparalleled throughput with an easy workflow, processing up to 160 samples per day and enabling fast and accurate diagnoses [1].

The system, which received FDA clearance, is designed to automate syndromic testing with automated loading and unloading of cartridges, priority handling of urgent samples, and minimal hands-on time. It integrates sample and assay technologies, bioinformatics, and automation systems to analyze biomolecules and provide actionable insights [2].

QIAGEN NV's Sample to Insight solutions transform biological samples into molecular insights, making biomolecules visible for analysis. The QIAstat-Dx Rise system 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 [1].

The first two panels for respiratory conditions are already available, and additional panels for both QIAstat-Dx and QIAstat-Dx Rise are in development. The system is already available in more than 100 countries, with over 4,600 instruments placed globally through the first half of 2025 [1].

This clearance marks QIAGEN’s third FDA-cleared QIAstat-Dx product in 2025, and builds on a growing portfolio of six panels cleared for the QIAstat-Dx family over the last 12 months. The system is designed to empower labs to automate and scale up testing with minimal hands-on time while delivering the detailed diagnostic insights needed for timely treatment decisions [1].

References:
[1] https://markets.ft.com/data/announce/detail?dockey=600-202509020130BIZWIRE_USPRX____20250901_BW414875-1
[2] https://www.marketscreener.com/news/qiagen-n-v-announces-750-million-convertible-bonds-due-2032-ce7c50dcda8bf127