QIAGEN receives FDA clearance for QIAstat-Dx mini panel to improve precision in outpatient respiratory treatment
Qiagen N.V. Common Shares (QGEN)
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Source: GlobeNewswire
Germantown, Maryland, and Venlo, the Netherlands, Oct. 29, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Respiratory Panel Mini test for clinical use. It is the third test to receive FDA clearance for use with QIAstat-Dx systems in 2024. The QIAstat-Dx Respiratory Panel Mini is designed to support clinical decision making in diagnosing upper respiratory infections in outpatient settings and covers five common viral causes of illness: influenza A, influenza B, human rhinovirus, respiratory syncytial virus (RSV) and SARS-CoV-2. The panel leverages QIAstat-Dx’s ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of
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