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QIAGEN's Syndromic QIAstat-Dx Test Granted FDA Clearance for Rapid and Accurate Respiratory Disease Diagnosis

Monday, May 13, 2024

QIAGEN (NYSE: QGEN; Frankfurter Prime Standard: QIA) has announced that the US Food and Drug Administration (FDA) has approved the clinical use of the QIAstat-Dx Respiratory Panel Plus for syndromic testing.

Designed to assist in diagnosing upper respiratory tract infections, the QIAstat-Dx Respiratory Panel targets 21 viral and bacterial pathogens to aid clinical decision-making. Previously authorized under an FDA Emergency Use Authorization (EUA) as the QIAstat-Dx Respiratory SARS-CoV-2 Panel, it employs QIAstat-Dx's real-time PCR technology to amplify multiple genetic targets simultaneously. Results are delivered in around an hour with minimal active work time, featuring easily interpretable cycle threshold (Ct values) and amplification curves, furnishing medical professionals with crucial clinical insights.

Fernando Beils, QIAGEN's senior vice president and head of molecular diagnostics, emphasized the panel's role in simplifying the diagnostic process and providing timely, accurate results. "The QIAstat-Dx respiratory panel addresses the challenges faced by doctors in diagnosing respiratory infections, streamlining the process and yielding accurate results in about an hour," said Beils. "This comprehensive diagnostic tool is poised to optimize patient care, encourage judicious antibiotic use, and alleviate the strain on healthcare systems."

Respiratory infections account for a significant portion of emergency room visits and hospitalizations, with the Centers for Disease Control and Prevention (CDC) estimating millions of influenza cases annually in the United States alone, resulting in substantial hospitalizations and deaths.

QIAGEN is actively broadening its testing portfolio for QIAstat-Dx in the US, with an FDA-approved gastrointestinal panel and a meningitis/encephalitis panel in the pipeline.

Syndromic testing systems like QIAstat-Dx have demonstrated enhanced co-infection detection capabilities, reducing the necessity for further testing. Rapid results enable healthcare providers to make informed decisions and curtail empirical antibiotic treatments upon detection of viral pathogens, consequently reducing overall antibiotic usage and supporting antibiotic stewardship.

Recently unveiled, the QIAstat-Dx Analyzer 2.0 introduces remote access to test results via the "Remote Results Application," facilitating seamless collaboration within the healthcare system. QIAstat-Dx syndromic testing, inclusive of cloud-based connectivity and epidemiology dashboards, is accessible in over 100 countries. To date, more than 4,000 instruments have been deployed worldwide.

Offering two versions, the QIAstat-Dx Analyzer accommodates up to four analysis modules, while the QIAstat-Dx Rise version enhances throughput, accommodating up to 160 tests daily with eight analysis modules.



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