The US Food and Drug Administration (FDA) has granted clearance to Qiagen’s QIAstat-Dx Gastrointestinal Panel 2 Mini B, expanding the company’s syndromic testing offerings in the US.
This clearance represents the company’s second FDA clearance for a QIAstat-Dx panel this year.
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It also builds on the authorisation of five panels for use on the QIAstat-Dx system in the past ten months.
The company has secured regulatory approvals for three mini panels designed to detect respiratory and gastrointestinal conditions. These panels are intended for outpatient use, helping facilitate quick and informed treatment decisions.
The latest authorised panel targets bacterial infections, including Campylobacter, Shigella, Yersinia enterocolitica, and Salmonella, as well as Shiga-like toxin-producing Escherichia coli (STEC).
These pathogens are identified as primary causes of gastrointestinal illnesses by the Infectious Diseases Society of America.
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By GlobalDataThe panel “complements” the QIAstat-Dx Gastrointestinal Panel 2 Mini Bacterial & Viral (B&V), which also includes viral targets such as Norovirus.
According to the company, the latest authorised panel runs on the QIAstat-Dx system and utilises real-time PCR technology to amplify multiple genetic targets simultaneously, delivering results in approximately one hour with minimal hands-on time.
Laboratories will benefit from cycle threshold values and amplification curves for additional insights, especially in cases of co-infections, viewable directly on the system’s touchscreen, stated the company.
Qiagen infectious diseases head and vice president 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 is tailored for settings prioritising bacterial pathogens while the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V panel addresses both bacterial and viral targets, stated the company.
These panels, along with the 16-target QIAstat-Dx Gastrointestinal Panel 2 which is approved by the FDA for hospitalised patients, meet the diagnostic requirements in both inpatient and outpatient settings.
In November 2024, the company announced a new site in Esplugues de Llobregat, Spain, for shifting its QIAstat-Dx system operations.
