( MENAFN - GlobeNewsWire - Nasdaq) QIAstat-Dx Respiratory Panel Mini targets the five most actionable respiratory pathogens in outpatient settings to help clinicians make precise treatment decisions // With the new test and the 21-target QIAstat-Dx Respiratory Panel Plus, clinicians can fine-tune their diagnostic approach for individual patients, promoting better diagnostic stewardship // FDA decision marks third positive U.S. regulatory outcome for QIAstat-Dx to date in 2024 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 co-infections, and are in.