QIAGEN receives FDA clearance for QIAstat-Dx respiratory syndromic testing panel for fast and accurate results

14 May 2024


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 Plus syndromic test for clinical use.

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 (EUA) as the QIAstat-Dx Respiratory SARS-CoV-2 Panel. The panel leverages QIAstat-Dx’s ability to quickly amplify many genetic targets at once using real-time PCR technology, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves are easily viewable and provide healthcare professionals with additional clinical information.

“The QIAstat-Dx Respiratory Panel Plus addresses the challenges faced by clinicians in diagnosing respiratory infections, streamlining the process and providing accurate results in about one hour,” said Fernando Beils, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN. “This comprehensive diagnostic tool will improve patient care, support responsible antimicrobial stewardship, and reduce the burden on healthcare systems.”

Respiratory tract infections are the leading cause of emergency department visits and hospitalizations. The CDC estimates that up to 41 million cases of influenza occur each year in the U.S., leading to several hundred thousand hospitalizations and up to 51,000 deaths.[1]

QIAGEN 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.

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

QIAGEN recently launched the QIAstat-Dx Analyzer 2.0 [2]. The upgraded diagnostic system introduces the Remote Results Application, a unique feature in the syndromic testing space. It allows users to view, comment on, and confirm diagnostic test results directly from their desktop and mobile devices in any location, facilitating seamless collaboration across the healthcare system. QIAstat-Dx syndromic testing with cloud-based connectivity and epidemiological insights is available in more than 100 countries, with more than 4,000 instruments placed worldwide.

QIAstat-Dx is available in two formats: the QIAstat-Dx Analyzer version, which integrates up to four Analytical Modules, and the QIAstat-Dx Rise higher-capacity version, providing comprehensive testing for up to 160 tests per day using eight Analytical Modules [2].

More information on the QIAstat-Dx portfolio can be found here: https://www.qiagen.com/applications/syndromic-testing/products

[1] Centers for Disease Control and Prevention: “Disease burden of flu”, https://www.cdc.gov/flu/about/burden/index.html
[2] Product availability may differ from country to country based on regulations and approvals.



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