QIAGEN secures U.S. clearance for first QIAstat-Dx mini gastrointestinal panel to support year-round outpatient care

Rhea-AI Summary

QIAGEN (NYSE: QGEN) has secured FDA clearance for its QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, marking the first in a series of gastrointestinal panel tests. The panel covers five key causes of gastrointestinal illness recommended by the IDSA, including four bacteria and Norovirus.

This clearance makes QIAGEN the first company to offer both comprehensive and targeted syndromic gastrointestinal panels, enhancing diagnostic flexibility for healthcare providers. The test delivers results in about one hour with minimal hands-on time.

A second version covering five bacterial pathogens is planned for FDA submission. Additionally, QIAGEN plans to submit its higher-capacity QIAstat-Dx Rise instrument for FDA clearance in early 2025, which can process up to 160 tests daily using eight Analytical Modules.

Positive

• First company to offer both comprehensive and targeted syndromic gastrointestinal panels
• FDA clearance secured for new QIAstat-Dx Gastrointestinal Panel
• Expanding market presence with over 4,000 instruments placed worldwide in 100+ countries
• Development of higher-capacity QIAstat-Dx Rise system (160 tests/day vs current capacity)

Negative

• None.

Insights

Medical Device Analyst

The FDA clearance of QIAGEN's QIAstat-Dx Gastrointestinal Panel 2 Mini B&V represents a strategic market expansion in the $2.5 billion global syndromic testing market. The panel's ability to detect five key pathogens in about one hour positions QIAGEN advantageously in the outpatient diagnostics segment. The dual offering strategy - comprehensive panels for hospitals and targeted mini panels for outpatient settings - creates significant revenue diversification opportunities and addresses different reimbursement scenarios.

The upcoming QIAstat-Dx Rise platform, with double the testing capacity, could potentially increase testing throughput by 100% to 160 tests daily. This scalability feature is particularly attractive for high-volume testing centers and could drive higher consumable sales. The installed base of 4,000+ instruments globally provides a strong foundation for recurring revenue through test cartridge sales.

Healthcare Market Analyst

The timing of this clearance aligns perfectly with the growing demand for rapid diagnostic solutions in the outpatient setting. With 179 million estimated cases of acute infectious gastroenteritis annually in the U.S., the market opportunity is substantial. The streamlined five-pathogen panel specifically targets the most common and actionable pathogens, optimizing both clinical utility and cost-effectiveness for outpatient facilities.

QIAGEN's strategic positioning as the only provider offering both comprehensive and targeted panels creates a competitive moat in the syndromic testing market. The cloud-based connectivity feature enables real-time epidemiological insights, adding value beyond basic diagnostics and potentially creating additional revenue streams through data analytics services.

Financial Analyst

This regulatory milestone strengthens QIAGEN's market position in molecular diagnostics and could drive meaningful revenue growth. The dual-panel strategy effectively segments the market, enabling optimal pricing strategies while addressing different reimbursement scenarios. Based on the current installed base and market size, this product line could generate an estimated $200-300 million in annual revenue within 2-3 years.

The rapid succession of FDA clearances (4 in 2024 and more planned) demonstrates strong R&D execution and regulatory expertise. This regulatory momentum, combined with the planned launch of QIAstat-Dx Rise, sets up 2025 as a potential inflection point for QIAGEN's diagnostics business. The stock could see positive revaluation as these catalysts materialize.

• New QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (bacterial and viral) tailored to provide fast answers for outpatient diagnosis of gastrointestinal conditions

• QIAGEN the first to offer both comprehensive and targeted syndromic gastrointestinal panels, giving clinicians unmatched flexibility to optimize diagnostics for individual patients

• QIAstat-Dx Rise higher-capacity instrument version to be submitted in early 2025 for U.S. regulatory clearance, builds on groundbreaking 2024 clearances of four QIAstat-Dx Panels

GERMANTOWN, Md., & VENLO, The Netherlands--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. regulatory clearance of the first in a series of QIAstat-Dx Gastrointestinal Panel tests for clinical use.

This clearance by the U.S. Food and Drug Administration (FDA) marks the second mini syndromic panel in the U.S. and made available for use with QIAstat-Dx systems, supporting QIAGEN's strategy to improve patient treatment options in this important market.

The 2025 clearance involves the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (bacterial and viral) covering five causes of gastrointestinal illness that are recommended by the Infectious Diseases Society of America (IDSA): the bacteria Campylobacter, Salmonella, Shiga-like toxin E.Coli (STEC) and Shigella, along with Norovirus, one of the most common causes of gastrointestinal infection and an important target during the winter season.

A second version of the Gastrointestinal Panel covering five common bacterial pathogens that cause gastrointestinal infections (Campylobacter, Salmonella, STEC, Shigella and Yersinia enterocolitica) is also planned to be submitted to the FDA for clearance in the coming weeks.

Acute infectious gastroenteritis is a leading cause of outpatient visits and hospitalizations in the U.S., with over 179 million estimated cases per year.¹

“QIAGEN has the only offering of both comprehensive and targeted syndromic panels for gastrointestinal testing. This provides dramatically new ways for clinicians to approach important diagnostics for inpatient and outpatient care,” said Nadia Aelbrecht, Vice President and Head of the Syndromic Testing Franchise at QIAGEN. “Our range of panels enables healthcare professionals to tailor testing to their specific needs, ensuring fast and accurate diagnosis while supporting better treatment decisions.”

This is the first QIAstat-Dx panel to receive FDA clearance in 2025 and comes after four FDA clearances were granted in 2024 for QIAstat-Dx panels. These panels in 2024 are designed to address critical needs in respiratory testing for both inpatient and outpatient settings, as well as diagnostics for gastrointestinal infections, meningitis and encephalitis.

QIAGEN also plans to submit QIAstat-Dx Rise, a higher-capacity version of the diagnostic instrument, for FDA clearance in early 2025.

This system provides comprehensive testing for up to 160 tests per day using eight Analytical Modules instead of four. QIAstat-Dx syndromic testing with cloud-based connectivity and epidemiological insights is available in more than 100 countries, with more than 4,000 instruments placed worldwide.

The QIAstat-Dx Gastrointestinal Panel 2 Mini B&V 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.

The FDA-approved 16-target QIAstat-Dx Gastrointestinal Panel 2 is highly suitable for hospitalized patients with risk factors for severe disease, while the more targeted QIAstat-Dx gastrointestinal mini panels offer a streamlined approach for diagnosing the most actionable pathogens causing gastrointestinal infections.

As a group, these three panels will address the distinct diagnostic needs of both inpatient and outpatient care, while also addressing a growing demand for flexible testing options that can address healthcare reimbursement challenges.

More information on the QIAstat-Dx portfolio can be found here: https://www.qiagen.com/product-categories/diagnostics-and-clinical-research/infectious-disease/qiastat-dx-syndromic-testing

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 September 30, 2024, QIAGEN employed more than 5,800 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.

Source: QIAGEN N.V.
Category: Corporate

1Moon RC, Bleak TC, Rosenthal NA, et al. Epidemiology and Economic Burden of Acute Infectious Gastroenteritis Among Adults Treated in Outpatient Settings in US Health Systems [published online ahead of print, 2023 Feb 3]. Am J Gastroenterol. 2023;10.14309/ajg.0000000000002186. doi:10.14309/ajg.0000000000002186

 

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Investor Relations

John Gilardi, +49 2103 29 11711

Domenica Martorana, +49 2103 29 11244

e-mail: ir@QIAGEN.com



Public Relations

Thomas Theuringer, +49 2103 29 11826

Lisa Specht, +49 2103 29 14181

e-mail: pr@QIAGEN.com

Source: QIAGEN N.V.

FAQ

What is QIAGEN's new FDA-cleared gastrointestinal panel test in 2025?

QIAGEN received FDA clearance for the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, which tests for five causes of gastrointestinal illness including four bacteria and Norovirus.

How long does the new QGEN QIAstat-Dx gastrointestinal test take to deliver results?

The QIAstat-Dx Gastrointestinal Panel delivers results in about one hour with less than one minute of hands-on time.

What is the testing capacity of QIAGEN's upcoming QIAstat-Dx Rise system?

The QIAstat-Dx Rise system will be able to process up to 160 tests per day using eight Analytical Modules, compared to the current system's four modules.

How many QIAstat-Dx instruments has QGEN placed worldwide?

QIAGEN has placed more than 4,000 QIAstat-Dx instruments across more than 100 countries worldwide.

When will QGEN submit the QIAstat-Dx Rise system for FDA clearance?

QIAGEN plans to submit the QIAstat-Dx Rise system for FDA clearance in early 2025.