QIAGEN Gains FDA Clearance for Latest Respiratory Mini-Panel Test

The U.S. Food and Drug Administration (FDA) has cleared QIAGEN’s QIAstat-Dx Respiratory Panel Mini test for clinical use—the third such assay to be authorized for use this year with the company’s QIAstat-Dx systems.

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 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 an 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. This makes it an invaluable tool in outpatient settings, where its efficiency can benefit the widest possible patient population. The two FDA-cleared tests together tackle the challenges clinicians encounter when diagnosing respiratory infections in both outpatient and inpatient settings.

“The QIAstat-Dx Respiratory Panel Mini and QIAstat-Dx Respiratory Panel Plus will improve diagnostic stewardship by enabling clinicians to tailor testing to each patient’s unique needs, choosing between a full, comprehensive panel or a more targeted one,” QIAGEN Vice President/Head of the Syndromic Testing Franchise Nadia Aelbrecht said. “By streamlining the diagnostic process and delivering accurate results in about an hour for both outpatient and inpatient groups, these tests will enhance patient care, promote responsible antimicrobial stewardship and alleviate the strain 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 United States, leading to several hundred thousand hospitalizations and up to 51,000 deaths.¹

Syndromic tests like QIAstat-Dx have been shown to improve the infection detection, 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 launch of the QIAstat-Dx Analyzer 2.0, FDA clearance of the Gastrointestinal Panel 2, and submission for the Meningitis/Encephalitis Panel.

After its launch in Europe in spring 2024, the QIAstat-Dx Analyzer 2.0 is now also available in the United States for use with the QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Gastrointestinal Panel 2. An extension for use with the QIAstat-Dx Respiratory Panel Mini is already planned. 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.

The QIAstat-Dx Rise higher‑capacity version provides comprehensive testing for up to 160 tests per day using eight Analytical Modules instead of four. It is available in Europe and other countries that accept CE Mark approval and is planned for FDA submission next year.² QIAstat-Dx syndromic testing with cloud-based connectivity and epidemiological insights is available in more than 100 countries, with 4,000-plus instruments placed worldwide.

QIAGEN N.V., a Netherlands-based holding company, provides Sample-to-Insight solutions that enable customers to gain valuable molecular insights from samples containing life’s building blocks. The company’s sample technologies isolate and process DNA, RNA, and proteins from blood, tissue, and other materials. Assay technologies make these biomolecules visible and ready for analysis while bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers worldwide in molecular diagnostics (human healthcare) and life sciences (academia, pharmaceutical R&D, and industrial applications, primarily forensics). As of June 30, 2024 QIAGEN employed more than 5,900 people in over 35 locations worldwide.

References
¹ https://www.cdc.gov/flu/about/burden/index.html, as of June 28, 2024
² Product availability may differ from country to country based on regulations and approvals.