QIAGEN Wins FDA Nod for 2nd QIAstat-Dx Mini GI Panel

QIAGEN has received U.S. Food and Drug Administration (FDA) approval for its QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use.

This clearance marks QIAGEN’s second FDA nod of a QIAstat-Dx panel this year. It builds on authorization of five panels for use on the system within the last ten months. The company has now earned regulatory clearances for three mini panels to detect respiratory and gastrointestinal conditions, with these panels designed for outpatient use.

This newly authorized panel focuses solely on bacterial infections covering Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica. These are 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 system quickly multiplies many genetic targets using real-time PCR technology in the same reaction, delivering results in about an hour and with under one minute of hands-on time. The QIAstat-Dx Gastrointestinal Panel 2 Mini B is optimized for settings where bacterial pathogens are the primary concern.

QIAGEN plans to further expand its QIAstat-Dx portfolio and recently submitted the QIAstat-Dx Rise, a higher-capacity instrument designed to process up to 160 tests per day, for U.S. regulatory clearance.

“QIAGEN is committed to expanding its syndromic testing portfolio in the U.S. to provide laboratories and clinicians with targeted, efficient diagnostic solutions,” said Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN. “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 optimizing diagnostic workflows and offering them the flexibility they need.”