QIAGEN Gains FDA Approval for QIAstat-Dx Mini Panel, Enhancing Outpatient Respiratory Diagnostics with Rapid Results

QIAGEN Gains FDA Approval for QIAstat-Dx Mini Panel, Enhancing Outpatient Respiratory Diagnostics with Rapid Results

(IN BRIEF) QIAGEN has announced FDA clearance for its QIAstat-Dx Respiratory Panel Mini, marking the third such approval for the QIAstat-Dx system in 2024. Tailored for outpatient settings, this panel quickly detects five common respiratory pathogens—including influenza strains and SARS-CoV-2—enabling clinicians to make faster, more precise treatment decisions with results ready in about an hour. Designed to streamline diagnostic care, the mini panel complements the more comprehensive 21-target QIAstat-Dx Respiratory Panel Plus, which is suited for hospitalized patients at higher risk. With both panels available, healthcare providers can optimize testing based on patient needs, supporting better diagnostic stewardship and antimicrobial practices. QIAGEN’s expanded QIAstat-Dx portfolio now includes the recently launched Analyzer 2.0 in the U.S. and a high-capacity QIAstat-Dx Rise, which provides up to 160 tests daily and is available internationally.

(PRESS RELEASE) VENLO, 29-Oct-2024 — /EuropaWire/ — QIAGEN has secured U.S. FDA clearance for its QIAstat-Dx Respiratory Panel Mini, an innovative diagnostic tool tailored to aid in rapid and accurate diagnosis of respiratory infections in outpatient settings. Targeting five of the most common viral pathogens—such as influenza A, influenza B, RSV, and SARS-CoV-2—this new mini panel enhances QIAstat-Dx’s capabilities, offering results in about an hour with minimal hands-on time. This marks the third FDA clearance for QIAstat-Dx systems in 2024, underscoring the platform’s evolving role in high-speed diagnostic support.

The QIAstat-Dx Respiratory Panel Mini complements the broader QIAstat-Dx Respiratory Panel Plus, which features a 21-pathogen target range suited for more comprehensive testing needs in inpatient settings. Together, these panels empower clinicians to fine-tune their testing approach, whether focused or expansive, helping them make timely and well-informed treatment decisions. The ability to view amplification curves and cycle threshold values directly on the instrument further aids in interpreting results, particularly for cases with co-infections.

Nadia Aelbrecht, Vice President and Head of the Syndromic Testing Franchise at QIAGEN, remarked on the platform’s potential to enhance diagnostic stewardship: “The addition of the Respiratory Panel Mini strengthens our QIAstat-Dx offering, making it easier for healthcare providers to choose the right diagnostic approach. This technology streamlines the diagnostic process, reducing unnecessary tests and antibiotic use, and promoting responsible antimicrobial stewardship across outpatient and inpatient settings.”

Respiratory infections remain a leading cause of hospital visits in the U.S., with the CDC estimating up to 41 million annual flu cases alone. Syndromic testing solutions like QIAstat-Dx have been shown to enhance detection accuracy while reducing the need for follow-up testing, improving care pathways for both viral and bacterial infections.

QIAGEN’s QIAstat-Dx platform expansion in North America also includes the recent Analyzer 2.0 launch, FDA approval of the Gastrointestinal Panel 2, and plans for an upcoming submission of the Gastrointestinal Panel Mini. The Analyzer 2.0, now available in the U.S., introduces Remote Results Application, enabling secure access and collaboration on diagnostic results across healthcare teams via desktop and mobile devices.

The high-capacity QIAstat-Dx Rise, already available with CE-IVD marking in Europe, will join the QIAstat-Dx family with an expected FDA submission in 2025, offering increased throughput with its eight-module design. Across more than 100 countries, QIAstat-Dx continues to support healthcare with cloud-based connectivity and epidemiological insights, operating over 4,000 instruments worldwide.

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, 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, 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.cdc.gov/flu/about/burden/index.html, as of June 28, 2024
[2] Product availability may differ from country to country based on regulations and approvals.

Media Contacts:

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

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

SOURCE: QIAGEN