NEW YORK – Qiagen announced on Thursday that the US Food and Drug Administration has cleared an assay to detect five gastrointestinal pathogens on its syndromic QiaStat-Dx qPCR system.
The QiaStat-Dx Gastrointestinal Panel 2 Mini B detects Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica.
The Mini B is the second GI mini panel on the QiaStat-Dx system in the US, and the third mini panel overall.
The QiaStat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral), which was cleared by the FDA in January, detects the four of the same targets but substitutes Norovirus for Y. enterocolitica. Its QiaStat-Dx Respiratory Panel Mini, meanwhile, was cleared in October and detects influenza A, influenza B, human rhinovirus, respiratory syncytial virus, and SARS-CoV-2.
"Qiagen is committed to expanding its syndromic testing portfolio in the US to provide laboratories and clinicians with targeted, efficient diagnostic solutions,” Nadia Aelbrecht, VP and head of infectious diseases at the firm, said in a statement.
"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," Aelbrecht added.
Along with its 16-target QiaStat-Dx Gastrointestinal Panel 2, Qiagen said the panels can meet the "diagnostic needs of both inpatient and outpatient care, while also addressing a growing demand for flexible testing options that can address healthcare reimbursement challenges."
The QiaStat-Dx system is available in more than 100 countries, Qiagen said, with approximately 4,600 instruments placed globally. Qiagen recently submitted its higher-capacity instrument, called the QiaStat-Dx Rise, to the FDA and intends to further expand its QiaStat-Dx portfolio.