Netherlands-based Qiagen has announced the clearance of its QIAstat-Dx Gastrointestinal Panel 2 Mini B by the US Food and Drug Administration (FDA) for clinical use.
This FDA clearance represents the second QIAstat-Dx panel approved in 2025, contributing to a series of five panel authorisations over the past ten months. The panels are vital components of Qiagen’s expanding portfolio, which now includes detection tools for respiratory and gastrointestinal diseases.
The latest panel is designed to identify bacterial pathogens such as Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica.
These pathogens are highlighted by the Infectious Diseases Society of America for their role in gastrointestinal diseases. This panel complements an existing model that also targets viral agents, including Norovirus.
Qiagen vice president and infectious diseases head Nadia Aelbrecht said: “Qiagen is committed to expanding its syndromic testing portfolio in the US to provide laboratories and clinicians with targeted, efficient diagnostic solutions.
“With the FDA clearance of our second QIAstat-Dx mini gastrointestinal panel, we are further strengthening our ability to address diverse patient needs while supporting healthcare providers in optimising diagnostic workflows and offering them the flexibility they need.”
The QIAstat-Dx Gastrointestinal Panel 2 Mini B operates using Qiagen’s proprietary system, employing real-time PCR technology for rapid detection of multiple genetic markers.
Results are delivered approximately within an hour with minimal manual input required from laboratory staff. Additionally, the system provides cycle threshold values and amplification curves for enhanced contextual understanding.
Qiagen offers both broad-spectrum and focused syndromic testing solutions. This newly authorised panel caters to laboratories prioritising bacterial infections, while another previously approved panel addresses both bacterial and viral diagnostic needs.
Alongside the FDA-cleared 16-target panel tailored for patients at high risk of severe disease, these products meet varied diagnostic requirements across inpatient and outpatient settings.
Globally, the QIAstat-Dx system is said to have been deployed in more than 100 countries, with over 4,600 systems operational by the end of 2024.
Qiagen is preparing to broaden its product line further and has submitted the QIAstat-Dx Rise, a high-capacity device capable of processing up to 160 tests per day for US regulatory approval.
In January 2025, Qiagen achieved FDA clearance for its initial series of QIAstat-Dx Gastrointestinal Panel tests intended for clinical implementation.
