Qiagen N.V. has announced that the U.S. Food and Drug Administration (FDA) has cleared the use of all QIAstat-Dx Gastrointestinal (GI) Panels on the QIAstat-Dx Rise automated syndromic testing platform. The development marks the ninth FDA clearance for the company’s QIAstat-Dx panel portfolio in the past 24 months.

With the latest approval, laboratories in the United States can now run both QIAstat-Dx Respiratory Panels and QIAstat-Dx GI Panels on the QIAstat-Dx Rise system, a high-throughput version of the QIAstat-Dx platform. The system supports comprehensive syndromic testing that enables the detection of multiple pathogens linked to similar symptoms through a single test. In addition, targeted Mini panels allow laboratories to focus on a defined group of pathogens.

The QIAstat-Dx Rise system was introduced in the US in September 2025 to meet the growing demand for higher testing capacity and automation in molecular diagnostics laboratories. The platform is capable of processing up to 160 tests per day while requiring minimal hands-on time from laboratory personnel.

Designed with a smart drawer mechanism, the system automates cartridge loading and unloading, helping laboratories reduce manual handling and increase walkaway time. With up to eight analytical modules, laboratories can process 16 samples in a batch while maintaining dedicated slots for urgent samples, ensuring rapid turnaround for priority cases.

The newly cleared GI panels include QIAstat-Dx Gastrointestinal Panel 2, which detects 16 bacterial, viral and parasitic pathogens from a single stool sample, including clinically relevant Shiga toxin-producing E. coli (STEC) subtypes. The portfolio also includes QIAstat-Dx GI Panel 2 Mini B and Mini B&V, which provide targeted detection of five gastrointestinal pathogens.

Using real-time PCR technology, the system delivers results in approximately one hour while requiring less than one minute of hands-on time per test. The platform also provides cycle threshold values and amplification curves in the same reaction, offering laboratories additional insights in cases of co-infection. Test results are displayed directly on the instrument touchscreen without the need for additional software.

The latest clearance expands the US portfolio to six panels available for the QIAstat-Dx system family. The platform has been adopted widely across global markets and is currently available in more than 100 countries, with over 5,200 instruments installed worldwide as of the end of 2025.

Syndromic testing platforms such as QIAstat-Dx help clinicians rapidly identify the cause of respiratory and gastrointestinal infections, which affect millions of patients each year, enabling faster treatment decisions and improved infection control.