QGEN Stock Set to Gain From FDA's Clearance of QIAstat-Dx Mini Panel

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QIAGEN N.V. QGEN recently achieved FDA clearance for its QIAstat-Dx Respiratory Panel Mini test for clinical use. This is the second QIAstat-Dx respiratory panel to receive U.S. regulatory nod this year.

The QIAstat-Dx Respiratory Panel Mini offers a streamlined approach for diagnosing the five most actionable pathogens causing upper respiratory infections: influenza A, influenza B, human rhinovirus, respiratory syncytial virus (RSV) and SARS-CoV-2. This is more targeted than the comprehensive 21-target QIAstat-Dx Respiratory Panel Plus, which is highly suitable for hospitalized patients with risk factors for severe disease.

QGEN Stock’s Likely Trend Following the News

Since the news was released on Oct. 29, QIAGEN’s shares have jumped 3.1% to close at $43.08 on Friday. The robust growth momentum in the QIAstat syndromic testing system is poised to continue, supported by new product launches in the United States. Accordingly, we expect market sentiment toward QGEN stock to remain positive surrounding this news.

QIAGEN currently has a market capitalization of $9.83 billion. According to the Zacks Consensus Estimate, the company’s 2024 earnings are expected to improve 3.9% on a 0.2% revenue increase. It delivered an average earnings surprse of 2.6% in the trailing four quarters.

Significance of QIAGEN’s QIAstat-Dx Respiratory Panel Mini

The QIAstat-Dx Respiratory Panel Mini leverages QIAstat-Dx’s ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, delivering results in about one 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. Together with the QIAstat-Dx respiratory syndromic testing panel, which received the FDA’s clearance in May this year, the tests effectively tackle the unique challenges that clinicians encounter when diagnosing respiratory infections in both outpatient and inpatient settings.

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Respiratory tract infections are the leading cause of emergency department visits and hospitalizations. Syndromic tests like QIAstat-Dx have been shown to improve infection detection, including multiple pathogens, reducing the need for additional testing. These provide fast results, enabling healthcare providers to make informed treatment decisions and discontinue empiric antibiotic treatment when viral pathogens are detected. This reduces overall antibiotic usage and supports the goal of responsible antimicrobial stewardship.