Germany-based molecular testing provider Qiagen has announced the US Food and Drug Administration (FDA) approval and US launch of its new syndromic testing system, QIAstat-Dx Rise.
The QIAstat-Dx Rise system supports the simultaneous detection of multiple genetic targets through real-time polymerase chain reaction (PCR) technology.
It allows hospitals and laboratories to process up to 160 samples daily. The system is also said to enable automated loading and unloading of cartridges, with minimal manual intervention.
Its real-time PCR-based pathogen detection enhances test capacity, maintaining rapid diagnostics crucial in settings requiring quick results.
According to Qiagen, the system delivers test results within one hour, offering less than one minute of hands-on time.
Also, it provides cycle threshold values and amplification curves for detailed analysis, which can be accessed directly on the instrument’s touchscreen without additional software.
The US launch of the QIAstat-Dx Rise system includes a Respiratory Panel Plus and Respiratory Panel Mini, with more panels under development, said Qiagen.
Qiagen vice president and infectious diseases head Nadia Aelbrecht said: “The launch of QIAstat-Dx Rise marks a significant step forward in our commitment to expand access to infectious disease diagnostics across the US and builds on the expansion efforts for this system in other areas of the world.
“QIAstat-Dx builds on the strong customer response to the lower-throughput version, empowering labs to automate and scale up testing with minimal hands-on time while delivering the detailed diagnostic insights needed for timely treatment decisions.”
Qiagen said that the commercial launch of QIAstat-Dx Rise in the US expands its instrument portfolio, building on its availability in Europe and other international markets.
It is the company’s third FDA-approved QIAstat-Dx family product this year, with six panels approved during the last 12 months.
Qiagen claimed that the QIAstat-Dx Rise system is already deployed in over 100 countries, with more than 4,600 units placed globally by mid-2025.
Furthermore, the company plans to extend the offering with gastrointestinal panels, including Gastrointestinal Panel 2, Gastrointestinal Mini B&V, and Gastrointestinal Panel Mini B.
In June this year, Qiagen entered a collaboration with Incyte to develop a companion diagnostic panel for identifying patients with mutant calreticulin (mutCALR).
