FDA Clears First QIAstat-Dx Mini Gastrointestinal Panel

QIAGEN has won U.S. Food and Drug Administration (FDA) clearance for the first in a series of QIAstat-Dx Gastrointestinal Panel tests. The authorization is the second mini syndromic panel made available for use in the United States with QIAstat-Dx systems.

The 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 expected to be submitted to the FDA for approval.

Acute infectious gastroenteritis is a leading cause of outpatient visits and U.S. hospitalizations, with more than 179 million estimated cases annually.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 occurs after four FDA clearances were granted in 2024 for QIAstat-Dx panels. The panels approved 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 plans to submit QIAstat-Dx Rise, a higher-capacity version of the diagnostic instrument, for FDA clearance.

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 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.

A Netherlands-based holding company, QIAGEN is a global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Its 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 and automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers worldwide in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of Sept. 30, 2024, QIAGEN employed more than 5,800 people in over 35 locations worldwide.

Reference
¹ Moon 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