QIAGEN receives FDA clearance for QIAstat-Dx mini panel to improve outpatient respiratory treatment

QIAGEN has 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 instantly viewable on the instrument touchscreen with no additional software required.

The QIAstat-Dx Respiratory Panel Mini is the second QIAstat-Dx respiratory panel to receive FDA clearance this year. While the comprehensive 21-target QIAstat-Dx Respiratory Panel Plus is highly suitable for hospitalized patients with risk factors for severe disease, the more targeted QIAstat-Dx Respiratory Panel Mini offers a streamlined approach for diagnosing the five most actionable pathogens causing upper respiratory infections. The two FDA-cleared tests together effectively tackle the unique challenges that clinicians encounter when diagnosing respiratory infections in both outpatient and inpatient settings.

Syndromic tests like QIAstat-Dx have been shown to improve the detection of infections, including those involving multiple pathogens, reducing the need for additional testing. By providing fast results, syndromic testing enables healthcare providers to make informed treatment decisions and discontinue empiric antibiotic treatment when viral pathogens are detected, reducing overall antibiotic usage and supporting the goal of responsible antimicrobial stewardship.

QIAGEN is expanding its portfolio for QIAstat-Dx in North America, with the recent launch of the QIAstat-Dx Analyzer 2.0, FDA clearance of the Gastrointestinal Panel 2 and submission for FDA clearance of the Meningitis/Encephalitis Panel. Submission for FDA clearance of the Gastrointestinal Panel Mini is planned before the end of this year.

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