QIAGEN 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, Salmoneella, STEC, Shigella and Yersinia enterocolitica) is also planned to be submitted to the FDA for clearance in the coming weeks. 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. QIAGEN also plans to submit QIAstat-Dx Rise, a higher-capacity version of the diagnostic instrument, for FDA clearance in early 2025.

The QIAstat-Dx gastrorointestinal 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. The FDA-approved 16-target QIAstat-DxG 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. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights.

Automation solutions tie these together in seamless and cost-effective workflows. 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 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); ability to obtain regulatory approval of 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 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 economic economic conditions; and other factors; and other factors); and ability to obtain regulatory approval of QIAGEN's products; difficulties in successfully adapt QIAGEN's products to integrate solutions and producing such products; difficulties in successfully adaptingQIAGEN's products; the ability of QiaGEN's products to integrated solutions; the ability of QIAgen to identify and develop new products, and to identify and develop new products.