QIAGEN receives U.S. clearance for second QIAstat-Dx mini gastrointestinal panel
QIAGEN announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use.
This marks QIAGEN’s second FDA clearance of a QIAstat-Dx panel in 2025 and builds on the authorization of five panels for use on the QIAstat-Dx system within the last 10 months.
QIAGEN has now received regulatory clearances for three mini panels for detection of respiratory and gastrointestinal conditions, with these panels designed for outpatient use to aid fast and informed treatment decisions.
This newly authorized panel focuses solely on bacterial infections covering Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica – all recognized by the Infectious Diseases Society of America (IDSA) as leading causes of gastrointestinal illness. It is designed to complement the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral) that covers Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Norovirus.
The QIAstat-Dx Gastrointestinal Panel 2 Mini B runs on QIAGEN’s QIAstat-Dx system and leverages its ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of coinfections and‑ are instantly viewable on the instrument touchscreen with no additional software required.
QIAGEN is the first company to offer both comprehensive and targeted syndromic gastrointestinal panels, allowing laboratories to tailor testing to their specific requirements. The QIAstat-Dx Gastrointestinal Panel 2 Mini B is optimized for settings where bacterial pathogens are the primary concern, complementing the previously cleared QIAstat-Dx Gastrointestinal Panel 2 Mini B&V panel, which includes both bacterial and viral targets.
