QIAGEN (QGEN) Wins FDA Nod for QIAstat-Dx Respiratory Panel Plus

QIAGEN N.V. QGEN recently secured FDA clearance for the QIAstat-Dx Respiratory Panel Plus syndromic test. Previously authorized under the FDA Emergency Use Authorization (“EUA”) as the QIAstat-Dx Respiratory SARS-CoV-2 Panel, the test is designed to support clinical decision-making in diagnosing upper respiratory infections and covers 21 viral and bacterial targets.

The latest development will strongly boost the company’s Molecular Diagnostics business.

Significance of the QIAstat-Dx Respiratory Panel Plus

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. Against this backdrop, QIAGEN’S new comprehensive diagnostic tool is expected to improve patient care, support responsible antimicrobial stewardship and reduce the burden on healthcare systems.

The QIAstat-Dx Respiratory Panel Plus leverages QIAstat-Dx’s ability to quickly amplify many genetic targets at once using real-time PCR technology, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves are easily viewable and provide healthcare professionals with additional clinical information. Additionally, the company is working on expanding its portfolio for QIAstat-Dx in the United States, with a Gastrointestinal Panel currently under FDA review and a Meningitis/Encephalitis Panel.

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Syndromic testing systems like QIAstat-Dx have been shown to improve the detection of co-infections, reducing the need for additional testing. By providing fast results, syndromic testing enables healthcare providers to make informed decisions and discontinue empiric antibiotic treatment when viral pathogens are detected, reducing overall antibiotic usage and supporting the goal of responsible antimicrobial stewardship.

QIAstat???Dx is available in two formats — the QIAstat-Dx Analyzer version, which integrates up to four Analytical Modules, and the QIAstat-Dx Rise higher-capacity version, which provides comprehensive testing for up to 160 tests per day using eight Analytical Modules.

Industry Prospects

Per a Research report, the Syndromic Multiplex Diagnostic market has an estimated valuation of $2.68 billion in 2024 and a CAGR of 7.66% through 2029. 

The market is driven by factors such as the growing burden of diseases in recent years, thereby creating a higher demand for accurate and rapid test results. Furthermore, the Gastrointestinal segment is expected to hold a significant share in the market throughout the forecast period, supported by the advantages of technologically advanced panels developed for these diseases.

Recent Developments in the Molecular Diagnostics Group

In March 2024, QIAGEN launched the QIAstat-Dx Analyzer 2.0, including the Software 1.6 upgrade, a significant enhancement to the widely-used QIAstat-Dx Analyzer 1.0 for fast and cost-effective diagnosis of complex syndromes. The upgraded diagnostic system introduces the Remote Results Application feature, still unique 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 company also partnered with the International Panel Physicians Association to support and educate panel physicians around the globe on the latest tuberculosis (TB) screening requirements. The joint educational initiative will focus on the use of Interferon Gamma Release Assay testing, such as QIAGEN’s QuantiFERON-TB Plus, to ensure a safe immigration process and support the global fight against TB.

Price Performance

In the past year, QGEN shares have dropped 5.2% compared with the industry’s 12.5% fall.

Zacks Rank and Key Picks

QIAGEN currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Hims & Hers Health HIMS, High Tide HITI and ResMed RMD. Each of them sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Hims & Hers Heath stock has increased 19.7% in the past year. Earnings estimates for the company have risen from 10 cents to 18 cents in 2024 and from 23 cents to 32 cents in 2025 in the past 30 days.

HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.

Estimates for High Tide’s 2024 earnings per share have remained breakeven in the past 30 days. Shares of the company have surged 69.7% upward in the past year against the industry’s fall of 3.2%.

HITI’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 91.7%. In the last reported quarter, it delivered an earnings surprise of 100%.

Estimates for ResMed’s fiscal 2024 earnings per share have moved up 2% to $7.59 in the past seven days. Shares of the company have fallen 6.3% in the past year compared with the industry’s 3.2% decrease.

RMD’s earnings surpassed estimates in three of the trailing four quarters and missed on one occasion, the average surprise being 2.8%. In the last reported quarter, it delivered an average earnings surprise of 10.9%.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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