QIAGEN has announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Respiratory Panel Mini for clinical use. This marks the third test to receive FDA clearance for use with QIAstat-Dx systems in 2024, and it is poised to improve diagnostic precision in outpatient respiratory treatment.
The QIAstat-Dx Respiratory Panel Mini is designed to aid clinical decision-making in diagnosing upper respiratory infections in outpatient settings. The panel covers five common viral causes of illness: influenza A, influenza B, human rhinovirus, respiratory syncytial virus (RSV) and SARS-CoV-2. Utilizing real-time PCR technology, the panel rapidly multiplies genetic targets, delivering results in about one hour with minimal hands-on time. The system also provides cycle threshold (Ct) values and amplification curves, offering additional information for co-infections, viewable on the instrument touchscreen.
Targeted Approach for Outpatient Settings
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 suited for hospitalized patients with risk factors for severe disease, the Mini panel 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 a broader patient population.
Nadia Aelbrecht, Vice President and Head of the Syndromic Testing Franchise at QIAGEN, stated, "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. 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."
Impact on Respiratory Infection Management
Respiratory tract infections are a significant 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 hundreds of thousands of hospitalizations and up to 51,000 deaths.
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.
Expanding QIAGEN's Diagnostic Portfolio
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.
After its launch in Europe in spring 2024, the QIAstat-Dx Analyzer 2.0 is now also available in the U.S. 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.
