FDA Clears QIAGEN’s Rapid QIAstat-Dx Panel for Meningitis and Encephalitis Diagnosis, Expanding Syndromic Test Portfolio

FDA Clears QIAGEN’s Rapid QIAstat-Dx Panel for Meningitis and Encephalitis Diagnosis, Expanding Syndromic Test Portfolio

(IN BRIEF) QIAGEN’s QIAstat-Dx Meningitis/Encephalitis Panel has received FDA clearance, enabling faster and more accurate diagnosis of critical CNS infections like meningitis and encephalitis. This panel, the fourth QIAstat-Dx test approved in the U.S. in 2024, uses real-time PCR to provide results in about an hour, addressing urgent needs in clinical settings where traditional methods may take over a day. This latest addition strengthens QIAGEN’s lineup of FDA-cleared panels for respiratory, gastrointestinal, and CNS infections.

(PRESS RELEASE) VENLO, 4-Nov-2024 — /EuropaWire/ — QIAGEN has received FDA clearance for its QIAstat-Dx Meningitis/Encephalitis Panel, making it the fourth QIAstat-Dx syndromic test approved in the U.S. this year. Designed for rapid diagnosis of critical central nervous system infections like meningitis and encephalitis, the panel provides results in approximately one hour using real-time PCR technology, offering a faster and more sensitive alternative to traditional microbiological testing, which can take over 24 hours. This rapid turnaround is vital, as meningitis and encephalitis require immediate treatment to prevent severe complications.

The QIAstat-Dx system not only detects multiple viral, bacterial, and fungal pathogens simultaneously but also includes cycle threshold values and amplification curves to give healthcare professionals additional diagnostic insights. This latest FDA clearance expands QIAGEN’s U.S. test menu, which now includes panels for respiratory, gastrointestinal, and CNS infections, reinforcing the company’s commitment to broadening its diagnostic offerings.

Fernando Beils, Senior Vice President at QIAGEN, highlighted the importance of the QIAstat-Dx system in supporting fast, evidence-based clinical decisions, emphasizing QIAGEN’s dedication to expanding syndromic testing solutions.

About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our 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. 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 around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2024, QIAGEN employed more than 5,900 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement
Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, collaborations, markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission.

[1] https://www.who.int/news-room/fact-sheets/detail/meningitis, as of October 30, 2024
[2] https://www.cdc.gov/meningococcal/php/surveillance/index.html, as of October 30, 2024

Media Contacts:

Lisa Specht
Manager Public Relations
Germany: +49 2103 29 14181
Mobile: +49 152 01811381
lisa.specht@qiagen.com

Dr. Thomas Theuringer
Senior Director Corporate Communications & Head Of External Communications
Germany: +49 2103 29 11826
Mobile: +49 1520 18 11826
thomas.theuringer@qiagen.com

SOURCE: QIAGEN