QIAGEN has received clearance from the US Food and Drug Administration (FDA) for its QIAstat-Dx Gastrointestinal Panel, part of a new series for clinical use.
The FDA clearance marks the second mini syndromic panel in the US for use with QIAstat-Dx systems.
It includes the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (bacterial and viral), detecting five key causes of gastrointestinal illness, Campylobacter, Salmonella, Shiga-like toxin E. coli (STEC), Shigella, and Norovirus.
These targets are recommended by the Infectious Diseases Society of America (IDSA), with Norovirus being especially significant during the winter season.
The QIAstat-Dx Gastrointestinal Panel 2 Mini B&V utilises real-time PCR technology to quickly detect multiple genetic targets in one reaction, delivering results in about one hour with less than one minute of hands-on time.
Cycle threshold (Ct) values and amplification curves offer valuable insights into co-infections, viewable instantly on the instrument touchscreen without additional software.
The FDA-approved 16-target QIAstat-Dx Gastrointestinal Panel 2 is ideal for hospitalised patients with risk factors for severe disease, while the more targeted mini panels focus on diagnosing the most actionable gastrointestinal pathogens.
Together, these three panels meet the diagnostic needs of both inpatient and outpatient care, addressing the growing demand for flexible testing solutions and healthcare reimbursement challenges.
A second version of the Gastrointestinal Panel, targeting five common bacterial pathogens, Campylobacter, Salmonella, STEC, Shigella, and Yersinia enterocolitica, is set for FDA submission in the coming weeks.
QIAGEN Syndromic Testing Franchise vice president and head Nadia Aelbrecht said: “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.”
This is the first QIAstat-Dx panel to receive FDA clearance in 2025, following four clearances in 2024. These panels addressed critical needs in respiratory testing, gastrointestinal infections, meningitis, and encephalitis for critical needs in both inpatient and outpatient settings.
The molecular diagnostics company plans to submit QIAstat-Dx Rise for FDA clearance in early 2025. This higher-capacity system can run up to 160 tests per day with eight analytical modules.
QIAstat-Dx syndromic testing, with cloud-based connectivity and epidemiological insights, is available in over 100 countries.
