QIAGEN receives CE-IVDR certification for full QIAstat-Dx test portfolio

VENLO, Netherlands - QIAGEN (NYSE:QGEN), a healthcare diagnostics company with a market capitalization of nearly $10 billion and impressive 80% gross profit margins, has secured CE-IVDR certification for its complete portfolio of QIAstat-Dx syndromic testing systems and panels, including an expanded Meningitis/Encephalitis (ME) Panel for central nervous system infections, the company announced Wednesday. According to InvestingPro data, QIAGEN maintains strong financial health with a "GREAT" overall score of 3.1 out of 5.

The newly certified ME Panel features 16 clinically relevant targets, making it the broadest coverage available for CNS infections. The panel now includes cytomegalovirus and Streptococcus pyogenes, with the latter being exclusive to QIAstat-Dx. The enhanced panel is expected to launch in September 2025, potentially contributing to the company’s projected revenue growth of 5% for fiscal year 2025.

QIAstat-Dx can deliver comprehensive results in approximately one hour, allowing clinicians to make faster treatment decisions. The system is available in over 100 countries, including the United States and throughout Europe, with more than 4,600 systems installed globally by the end of 2024.

The diagnostic platform comes in two formats: the QIAstat-Dx Analyzer that integrates up to four Analytical Modules, and the higher-capacity QIAstat-Dx Rise that can process up to 160 tests daily using eight Analytical Modules. Both platforms received CE-marking under the IVDR framework late last year.

"Achieving IVDR certification for our complete QIAstat-Dx portfolio marks a major milestone for QIAGEN and the laboratories and clinicians we serve," said Nadia Aelbrecht, Vice President, Head of Infectious Diseases at QIAGEN, according to the press release.

The certification demonstrates QIAGEN’s compliance with the European Union’s new regulatory framework for in vitro diagnostic devices, which replaced the previous directive to improve patient safety and transparency. With a stable financial position and moderate debt levels, QIAGEN continues to strengthen its market presence. For deeper insights into QIAGEN’s financial health and growth prospects, including 8 additional ProTips and comprehensive analysis, visit InvestingPro, where you’ll find detailed research reports and expert analysis.

In other recent news, Qiagen NV reported its Q2 2025 earnings, meeting earnings per share (EPS) expectations at $0.60. The company exceeded revenue forecasts with $534 million, representing a 1.93% positive surprise. This development comes amid cautious market sentiment, which may be influenced by the flat EPS performance and ongoing challenges in key markets. Despite the revenue beat, the company’s stock experienced a decline after the earnings announcement. Analysts and investors are closely monitoring these developments to assess the company’s performance in the coming quarters. The earnings results provide essential insights into Qiagen’s financial health and market position. These recent developments highlight the importance of revenue and earnings data for stakeholders.

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