Qiagen gets FDA clearance for respiratory syndromic testing panel

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Qiagen announced that it has received U.S. Food and Drug Administration (FDA) clearance for its QIAstat-Dx respiratory syndromic testing panel for clinical use.

The QIAstat-Dx Respiratory Panel Plus, previously authorized under an FDA emergency use authorization as the QIAstat-Dx Respiratory SARS-CoV-2 Panel, covers 21 viral and bacterial targets, amplifying many genetic targets at once using real-time polymerase chain reaction (PCR) technology to deliver results in an hour. Furthermore, syndromic testing systems like QIAstat-Dx enable the detection of co-infections.

Qiagen recently launched its upgraded QIAstat-Dx Analyzer 2.0 diagnostic system, which introduces an application that allows users to view, comment on, and confirm diagnostic test results directly from their desktop and mobile devices in any location.

Qiagen is currently working on expanding the QIAstat-Dx test menu in the U.S.; a meningitis/encephalitis panel is in development, and a gastrointestinal panel is currently under FDA review.        

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