The US Food and Drug Administration (FDA) has cleared a new, higher throughput version of Qiagen’s automated syndromic testing system, expanding the company’s commercial portfolio of pathogen tests.
QIAstat-Dx Rise uses real-time polymerase chain reaction (PCR)-based detection of multiple pathogens from a single sample, yielding results within one hour.
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Ideating on the Dutch company’s previous system, Dx Rise provides simultaneous testing for up to eight panels with a throughput of up to 160 samples per day, up from four panels and a throughput of 60-80 samples per day with its QIAstat-Dx Analyzer.
According to Qiagen, with Dx Rise’s provision of automated cartridge loading and unloading, access to priority handling of urgent samples and a minimum of hands-on time, the new system meets the needs of hospitals and labs seeking “highly automated” syndromic testing.
Qiagen vice-president and head of infectious diseases Nadia Aelbrecht commented: “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.”
QIAstat-Dx Rise’s FDA clearance continues what has been a fruitful period for Qiagen. Earlier this year, the FDA cleared the company’s QIAstat-Dx Gastrointestinal Panel 2 Mini B. Designed for outpatient use, the panel detects five major bacterial pathogens in Campylobacter, Salmonella, STEC, Shigella, and Yersinia enterocolitica. Qiagen also gained clearance on its mini bacteria and virus (B&V) panel, adding Norovirus to the bacterial pathogen panel.
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By GlobalDataDx Rise currently supports Qiagen’s Respiratory Panel Plus and Respiratory Panel Mini for the detection of viral and bacterial pathogens, including SARS-CoV-2, influenza A/B, RSV A/B adenovirus, and rhinovirus/enterovirus.
The company said it plans to add its family of gastrointestinal panels, including QIAstat-Dx Gastrointestinal Panel 2, QIAstat-Dx Gastrointestinal Mini B&V and QIAstat-Dx Gastrointestinal Panel Mini B to Dx Rise over the coming months.
In 2024, Qiagen was granted FDA clearance for four additional QIAstat-Dx panels, the most recent being the QIAstat-Dx meningitis/encephalitis panel for diagnosing central nervous system infections in November.
In addition, Qiagen also announced plans last year to open a new site for its QIAstat-Dx system operations in Barcelona, Spain. Scheduled to be fully operational in early 2026, the new facility will encompass the complete value chain for Qiagen’s product range.
