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QIAGEN’s QIAstat-Dx Respiratory Syndromic Testing Panel Cleared by FDA for Rapid and Precise Diagnosis

NextEdge Admin

13 May 2024

3 min 6 sec

QIAGEN has received clearance from the U.S. Food and Drug Administration (FDA) for the clinical use of the QIAstat-Dx Respiratory Panel Plus syndromic test. This test is a significant advancement in diagnosing upper respiratory infections, covering 21 viral and bacterial targets. It was previously authorized under Emergency Use Authorization (EUA) as the QIAstat-Dx Respiratory SARS-CoV-2 Panel.

The QIAstat-Dx Respiratory Panel Plus utilizes real-time PCR technology to amplify multiple genetic targets simultaneously, delivering results in about one hour with minimal hands-on time. This rapid turnaround time, along with easily viewable cycle threshold (Ct) values and amplification curves, provides healthcare professionals with valuable clinical information to aid in patient management.

Fernando Beils, Senior Vice President at QIAGEN, highlights the significance of this comprehensive diagnostic tool in improving patient care, supporting antimicrobial stewardship, and alleviating the burden on healthcare systems. Respiratory tract infections are a leading cause of emergency department visits and hospitalizations, with influenza alone causing significant morbidity and mortality each year in the U.S.

QIAGEN is also expanding its portfolio for the QIAstat-Dx platform, with a Gastrointestinal Panel currently under FDA review and a Meningitis/Encephalitis Panel in development. Syndromic testing systems like QIAstat-Dx have demonstrated efficacy in detecting co-infections, reducing the necessity for additional testing, and enabling healthcare providers to make informed decisions promptly.

The recent launch of the QIAstat-Dx Analyzer 2.0 introduces the Remote Results Application, a unique feature enabling users to access, comment on, and confirm test results from their desktop and mobile devices, fostering seamless collaboration across the healthcare system. QIAstat-Dx syndromic testing, with cloud-based connectivity and epidemiological insights, is available in over 100 countries, with over 4,000 instruments placed worldwide.

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