QIAGEN receives U.S. clearance for second QIAstat-Dx mini gastrointestinal panel, expanding U.S. syndromic testing portfolio

Rhea-AI Summary

QIAGEN (NYSE: QGEN) has received FDA clearance for its QIAstat-Dx Gastrointestinal Panel 2 Mini B, expanding its U.S. syndromic testing portfolio. This panel enables rapid detection of five common bacterial pathogens in outpatient settings, including Campylobacter, Salmonella, STEC, Shigella, and Yersinia enterocolitica.

This marks QIAGEN's second FDA clearance in 2025 and sixth regulatory clearance for QIAstat-Dx panels in the past 10 months. The new panel complements the existing QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, which covers both bacterial and viral targets.

The system delivers results in about one hour with minimal hands-on time, using real-time PCR technology. QIAGEN's QIAstat-Dx platform has achieved significant market penetration with over 4,600 instruments placed worldwide through 2024. The company is awaiting U.S. regulatory clearance for its new QIAstat-Dx Rise instrument, capable of processing up to 160 tests daily.

Positive

• FDA clearance received for new gastrointestinal diagnostic panel
• Six regulatory clearances achieved in last 10 months showing strong regulatory momentum
• Large installed base of 4,600+ instruments worldwide
• Expanding product portfolio with new high-capacity instrument pending approval

Negative

• None.

Insights

Medical Diagnostics Expert

QIAGEN's FDA clearance for their QIAstat-Dx Gastrointestinal Panel 2 Mini B represents a strategically significant advancement in syndromic testing. This panel targets five critical bacterial pathogens (Campylobacter, Salmonella, STEC, Shigella, and Yersinia enterocolitica) that are leading causes of gastrointestinal illness according to the IDSA.

What's particularly notable is QIAGEN's differentiated approach to the market - becoming the first company offering both comprehensive and targeted syndromic GI panels. This tiered approach allows healthcare providers to select appropriate testing complexity based on clinical setting, with the new panel optimized for outpatient environments where bacterial pathogens are the primary concern.

With acute infectious gastroenteritis causing approximately 179 million cases annually in the U.S. alone, the addressable market is substantial. The QIAstat-Dx system's rapid results (approximately one hour) with minimal hands-on time (less than one minute) addresses critical workflow efficiency needs in diagnostic laboratories.

This sixth regulatory clearance in ten months demonstrates exceptional regulatory execution, creating a comprehensive diagnostic ecosystem that strengthens QIAGEN's competitive positioning in syndromic testing. The pending QIAstat-Dx Rise platform, designed for higher throughput (up to 160 tests per day), will further enhance their market position by addressing varying capacity needs across healthcare settings.

Financial Analyst

This FDA clearance strengthens QIAGEN's recurring revenue model in the diagnostics segment. With over 4,600 QIAstat-Dx instruments already placed globally through 2024, each new test panel approval expands utilization opportunities across their installed base while potentially driving new placements.

The strategic value lies in QIAGEN's menu expansion approach, creating a portfolio that addresses both comprehensive testing needs (through their 16-target panel) and more targeted, cost-effective options through these "mini" panels. This flexibility allows healthcare providers to optimize testing based on clinical requirements while navigating reimbursement challenges - a critical consideration in today's healthcare economics landscape.

The gastrointestinal testing market represents a significant opportunity given the 179 million annual cases cited. By developing panels that specifically address outpatient use cases, QIAGEN is positioning to capture testing volume across the care continuum rather than just focusing on higher-acuity inpatient settings.

This approval represents the second FDA clearance in 2025 and the sixth within ten months, demonstrating accelerating regulatory momentum that should translate to expanded revenue opportunities. The pending QIAstat-Dx Rise platform would further enhance this growth trajectory by enabling higher throughput capacity.

The comprehensive ecosystem strategy - combining multiple panel options with varied instrument capacities - creates multiple paths for market penetration and revenue growth while establishing competitive barriers through menu breadth and instrument capabilities.

• New QIAstat-Dx Gastrointestinal Panel 2 Mini B adds to QIAGEN’s growing U.S. menu for syndromic testing of gastrointestinal infections

• Panel delivers rapid detection of five common bacterial pathogens for outpatient use, aiding fast and informed treatment decisions

• QIAGEN building momentum in the U.S. syndromic testing market with six regulatory clearance of panels for use on QIAstat-Dx within the last 10 months

GERMANTOWN, Md. & VENLO, Netherlands--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, further strengthening its syndromic testing portfolio in the United States.

This marks QIAGEN’s second FDA clearance of a QIAstat-Dx panel in 2025, and builds on the authorization of five panels for use on the QIAstat-Dx system within the last 10 months.

QIAGEN has now received regulatory clearances for three mini panels for detection of respiratory and gastrointestinal conditions, with these panels designed for outpatient use to aid fast and informed treatment decisions.

This newly authorized panel focuses solely on bacterial infections covering Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica – all recognized by the Infectious Diseases Society of America (IDSA) as leading causes of gastrointestinal illness. It is designed to complement the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral) that covers Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Norovirus.

Acute infectious gastroenteritis leads to an estimated 179 million cases annually in the U.S., driving significant numbers of outpatient visits and hospitalizations.¹

“QIAGEN is committed to expanding its syndromic testing portfolio in the U.S. to provide laboratories and clinicians with targeted, efficient diagnostic solutions,” said Nadia Aelbrecht, Vice President and Head of Infectious Diseases at QIAGEN. “With the FDA clearance of our second QIAstat-Dx mini gastrointestinal panel, we are further strengthening our ability to address diverse patient needs while supporting healthcare providers in optimizing diagnostic workflows and offering them the flexibility they need.”

The QIAstat-Dx Gastrointestinal Panel 2 Mini B runs on QIAGEN’s QIAstat-Dx system and leverages its 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.

QIAGEN is the first company to offer both comprehensive and targeted syndromic gastrointestinal panels, allowing laboratories to tailor testing to their specific requirements. The QIAstat-Dx Gastrointestinal Panel 2 Mini B is optimized for settings where bacterial pathogens are the primary concern, complementing the previously cleared QIAstat-Dx Gastrointestinal Panel 2 Mini B&V panel, which includes both bacterial and viral targets.

Together with the FDA-approved 16-target QIAstat-Dx Gastrointestinal Panel 2, which is highly suitable for hospitalized patients with risk factors for severe disease, these panels 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.

The QIAstat-Dx system is currently available in more than 100 countries, with over 4,600 instruments placed worldwide through the end of 2024. QIAGEN plans to further expand its QIAstat-Dx portfolio and has recently submitted the QIAstat-Dx Rise, a higher-capacity instrument designed to process up to 160 tests per day, for U.S. regulatory clearance.

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, enabling customers to extract and 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 prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of December 31, 2024, QIAGEN employed more than 5,700 people in over 35 locations worldwide. For more information, visit www.qiagen.com.

Forward-Looking Statement

Certain statements in this press release may constitute 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. These statements, including those regarding QIAGEN's products, development timelines, marketing and / or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results - such as expected adjusted net sales and adjusted diluted earnings - are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, regulatory processes and logistical dependencies), variability in operating results and allocations between customer classes, commercial development for our products to customers in the Life Sciences and clinical healthcare, changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancements; fluctuating demand for QIAGEN's products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN's products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other "force majeure" events. There is also no guarantee that anticipated benefits from acquisitions will materialize as expected. For a comprehensive overview of risks, please refer to the “Risk Factors” contained in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.
Category: Infectious Diseases

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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

View source version on businesswire.com: https://www.businesswire.com/news/home/20250305355588/en/

Contacts QIAGEN:

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 bacterial pathogens does the new QGEN QIAstat-Dx Gastrointestinal Panel 2 Mini B detect?

The panel detects five bacterial pathogens: Campylobacter, Salmonella, Shiga-like toxin-producing E. coli (STEC), Shigella, and Yersinia enterocolitica.

How many QIAstat-Dx instruments has QGEN placed globally by the end of 2024?

QIAGEN has placed over 4,600 QIAstat-Dx instruments worldwide through the end of 2024.

What is the processing time for QGEN's new QIAstat-Dx Gastrointestinal Panel 2 Mini B?

The panel delivers results in about one hour with less than one minute of hands-on time.

How many FDA clearances has QGEN received for QIAstat-Dx panels in the last 10 months?

QIAGEN has received six regulatory clearances for QIAstat-Dx panels within the last 10 months.

What is the testing capacity of QGEN's upcoming QIAstat-Dx Rise instrument?

The QIAstat-Dx Rise instrument is designed to process up to 160 tests per day.