QIAGEN Gains FDA Clearance for High-Throughput QIAstat-Dx Rise, Enhancing Syndromic Testing in the U.S
Reuters
Sep 02
QIAGEN Gains FDA Clearance for High-Throughput QIAstat-Dx Rise, Enhancing Syndromic Testing in the U.S
Qiagen NV has received U.S. FDA clearance for its QIAstat-Dx Rise, a high-throughput version of the QIAstat-Dx automated syndromic testing system. This approval enables the launch of QIAstat-Dx Rise in the U.S., which can process up to 160 samples per day. The system initially includes the Respiratory Panel Plus and Respiratory Panel Mini, with additional panels in development. This marks Qiagen's third FDA-cleared QIAstat-Dx product in 2025 and expands its portfolio of syndromic testing solutions, already available in over 100 countries. Plans are underway to introduce gastrointestinal panels to the system in the coming months.
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