Syndromic Panel Provides Fast Answers for Outpatient Diagnosis of Gastrointestinal Conditions

Acute infectious gastroenteritis is a major cause of outpatient visits and hospitalizations in the U.S., with over 179 million cases estimated annually. Now, a new gastrointestinal panel designed to provide fast answers for outpatient diagnosis of gastrointestinal conditions aims to support year-round outpatient care.

QIAGEN (Venlo, The Netherlands) has received U.S. regulatory approval for the first of its QIAstat-Dx Gastrointestinal Panel tests for clinical use. This approval by the U.S. Food and Drug Administration (FDA) marks the second mini syndromic panel available in the U.S. for use with QIAstat-Dx systems, aligning with QIAGEN's efforts to enhance patient treatment options in this critical market. This is the first QIAstat-Dx panel to receive FDA clearance in 2025, following four FDA clearances for QIAstat-Dx panels in 2024. The 2024 panels were aimed at meeting critical needs in respiratory testing for both inpatient and outpatient settings, as well as diagnosing gastrointestinal infections, meningitis, and encephalitis.

The 2025 FDA clearance pertains to the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (bacterial and viral), which covers five key causes of gastrointestinal illness as recommended by the Infectious Diseases Society of America. These include the bacteria Campylobacter, Salmonella, Shiga-like toxin-producing E. coli (STEC), and Shigella, as well as Norovirus, a common cause of gastrointestinal infections, especially during the winter season. The QIAstat-Dx Gastrointestinal Panel 2 Mini B&V leverages QIAstat-Dx’s real-time PCR technology, which rapidly amplifies multiple genetic targets in a single reaction, providing results in about one hour with less than one minute of hands-on time. The cycle threshold (Ct) values and amplification curves offer additional insight into co-infections, which can be instantly viewed on the instrument's touchscreen with no need for extra software.

A second version of the Gastrointestinal Panel, focusing on five common bacterial pathogens causing gastrointestinal infections (Campylobacter, Salmonella, STEC, Shigella, and Yersinia enterocolitica), is expected to be submitted to the FDA for clearance in the coming weeks. The FDA-approved 16-target QIAstat-Dx Gastrointestinal Panel 2 is ideal for hospitalized patients with severe disease risk factors, while the more targeted QIAstat-Dx gastrointestinal mini panels offer a streamlined approach for diagnosing the most relevant pathogens. Together, these panels will meet the diagnostic needs of both inpatient and outpatient care, while addressing the growing demand for flexible testing solutions that can manage healthcare reimbursement challenges. QIAGEN also plans to submit the QIAstat-Dx Rise, a higher-capacity diagnostic system, for FDA clearance in early 2025. This system can conduct up to 160 tests per day, utilizing eight Analytical Modules instead of four. QIAstat-Dx syndromic testing, with cloud-based connectivity and epidemiological insights, is available in over 100 countries, with more than 4,000 units installed globally.

“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.”