FDA Clears Qiagen's QIAstat-Dx Respiratory Syndromic Testing Panel

(RTTNews) - The U.S. Food and Drug Administration has cleared the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use, Qiagen N.V. (QGEN) said in a statement.

The QIAstat-Dx Respiratory Panel Plus is designed to support clinical decision-making in diagnosing upper respiratory infections and covers 21 viral and bacterial targets. It was previously authorized under a U.S. FDA Emergency Use Authorization.

The company noted that panel generates results in about one hour with less than one minute of hands-on time.

The company said that it is working on expanding its portfolio for QIAstat-Dx in the U.S., with a Gastrointestinal Panel currently under FDA review and a Meningitis/Encephalitis Panel.

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