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FDA approval
QIAGEN receives FDA clearance for QIAstat-Dx Respiratory Panel Plus test
Precision Medicine
May 13, 2024
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Precision Medicine

Precision Medicine

May 13, 2024

QIAGEN receives FDA clearance for QIAstat-Dx Respiratory Panel Plus test

FDA approval

  • QIAGEN has received FDA clearance for the clinical use of its QIAstat-Dx Respiratory Panel Plus syndromic test, a diagnostic tool designed for diagnosing upper respiratory infections. It was previously authorized under a US FDA Emergency Use Authorization (EUA) as the QIAstat-Dx Respiratory SARS-CoV-2 Panel.

  • The QIAstat-Dx Respiratory Panel Plus allows the detection of 21 viral and bacterial targets using real-time PCR technology. The product is claimed to provide results within an hour, including hands-on time up to one minute, viewing cycle threshold (Ct) values, and amplification curves to provide healthcare professionals with additional clinical information. QIAGEN is working on expanding its QIAstat-Dx portfolio in the US with a gastrointestinal panel under FDA review and a meningitis/encephalitis panel in development.

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