QIAGEN has received the US Food and Drug Administration (FDA) approval for its QIAstat-Dx Gastrointestinal Panel 2 Mini B, enhancing its syndromic testing portfolio in the US.
It is the second FDA clearance for a QIAstat-Dx panel this year, following the approval of five panels for the QIAstat-Dx system over the past ten months.
The panel targets bacterial infections, including Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica.
The pathogens are identified by the Infectious Diseases Society of America as major causes of gastrointestinal illness, said the company.
QIAGEN said the newly approved test panel complement the existing QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, which also covers Norovirus.
Currently, the company has regulatory approvals for three mini panels designed for outpatient use, supporting rapid treatment decisions.
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 on QIAGEN’s QIAstat-Dx system, using real-time PCR technology to deliver results within one hour.
The QIAstat-Dx system provides comprehensive and targeted syndromic gastrointestinal panels, allowing laboratories to customise testing to specific needs.
The newly approved test panel is optimised for settings prioritising bacterial pathogens, complementing the broader QIAstat-Dx Gastrointestinal Panel 2 Mini B&V.
The QIAstat-Dx Gastrointestinal Panel 2 Mini B addresses this need by offering quick and accurate diagnostic solutions.
QIAGEN’s QIAstat-Dx system is available in over 100 countries, with more than 4,600 instruments deployed globally by the end of 2024.
The company plans to expand its portfolio and has submitted the QIAstat-Dx Rise, a high-capacity instrument that can process up to 160 tests per day, for the US regulatory approval.
