Qiagen has received clearance from the US Food and Drug Administration (FDA) for the first in a planned series of gastrointestinal panels for clinical use.
For use with the Netherlands-based company’s QIAstat-Dx syndromic testing analyser, the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (bacterial and viral) covers five causes of gastrointestinal illness – the bacteria Campylobacter, Salmonella, shiga-like toxin E.coli (STEC) and Shigella, and norovirus – as recommended by the Infectious Diseases Society of America (IDSA).
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QIAstat-Dx uses real-time polymerase chain reaction (PCR) technology to multiply genetic targets within the same reaction and deliver test results in around one hour.
According to research, acute infectious gastroenteritis (AGE) is responsible for an estimated 179 million cases in the US each year.
Qiagen vice president and syndromic testing franchise head Nadia Aelbrecht commented: “Qiagen has the only offering of both comprehensive and targeted syndromic panels for gastrointestinal testing.
“This provides dramatically new ways for clinicians to approach important diagnostics for inpatient and outpatient care.
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By GlobalData“Our range of panels enables healthcare professionals to tailor testing to their specific needs, ensuring fast and accurate diagnosis while supporting better treatment decisions.”
Qiagen plans to submit a second gastrointestinal panel covering five of the most common bacterial pathogens responsible for gastrointestinal infections – Campylobacter, Salmonella, STEC, Shigella and Yersinia enterocolitica – for FDA clearance in the coming weeks, and also intends to submit QIAstat-Dx Rise, a higher-capacity version of its diagnostic system, for approval by the agency this year.
Throughout last year, Qiagen was granted FDA clearance for four QIAstat-Dx panels, the most recent being the QIAstat-Dx meningitis/encephalitis panel for diagnosing central nervous system infections in November 2024.
In the same month, the company announced plans to open a new site for its QIAstat-Dx system operations in Esplugues de Llobregat, Barcelona, Spain. Due to open early next year, the new facility will encompass the complete value chain for the QIAstat-Dx system.
In September 2024, Qiagen received a CE mark for its QIAstat-Dx syndromic testing systems and associated assays under the European Union’s In Vitro Diagnostic Regulation (IVDR).
