13.05.2024 08:45:15 - dpa-AFX: FDA Clears Qiagen's QIAstat-Dx Respiratory Syndromic Testing Panel
AMSTERDAM (dpa-AFX) - 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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