NEW YORK – The US Food and Drug Administration has granted clearance to Qiagen's targeted syndromic multiplex qPCR panel to detect bacterial and viral gastrointestinal infections.
The Gastrointestinal Panel 2 Mini B&V detects five pathogens: Campylobacter, Salmonella, Shiga-like toxin Escherichia coli (STEC), and Shigella bacteria, as well as norovirus. The one-hour test runs on the firm's QiaStat-Dx system with Ct values and amplification curves viewable on the instrument touchscreen.
Qiagen plans to submit a second version of the mini GI panel in the coming weeks, the firm said in a statement, targeting the same four bacterial pathogens but substituting Yersinia enterocolitica detection in place of norovirus.
The firm's 16-target GI panel, called the QiaStat-Dx Gastrointestinal Panel 2, was cleared by the FDA last year.
Qiagen is now the first vendor to offer both comprehensive and targeted syndromic GI panels, the firm said in a statement, adding that there are an estimated 179 million cases of acute infectious gastroenteritis in the US each year.
"Our range of panels enables healthcare professionals to tailor testing to their specific needs, ensuring fast and accurate diagnosis while supporting better treatment decisions," said Nadia Aelbrecht, VP and head of Qiagen's syndromic testing franchise.
Specifically, the 16-target GI panel is suitable for hospitalized patients with risk factors for severe disease, Qiagen said, while the targeted mini panels will offer streamlined diagnosis of the most actionable pathogens.
The firm obtained FDA marketing clearance for three other QiaStat-Dx panels in 2024 — Respiratory Panel Plus, Respiratory Panel Mini, and Meningitis/Encephalitis Panel — and it also plans to submit its higher-capacity QiaStat-Dx Rise instrument to the FDA in early 2025. The Rise system, with more than 4,000 placements globally already, can perform up to 160 tests per day, Qiagen said.