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Qiagen Secures FDA Clearance for QIAstat-Dx Gastrointestinal Panel

NextEdge Admin

11 Jan 2025

2 min 13 sec

FDA Clearance,Gastrointestinal Panel,PCR technology,syndromic testing

Qiagen has secured FDA clearance for its QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, the first in a planned series of gastrointestinal diagnostic panels. Designed for use with the QIAstat-Dx syndromic testing analyzer, the panel detects five key bacterial and viral pathogens—Campylobacter, Salmonella, shiga-like toxin E. coli (STEC), Shigella, and norovirus—aligned with Infectious Diseases Society of America (IDSA) recommendations.

Utilizing real-time PCR technology, QIAstat-Dx enables rapid genetic target amplification, delivering test results in approximately one hour. Acute infectious gastroenteritis (AGE) accounts for an estimated 179 million cases annually in the U.S., highlighting the clinical importance of rapid diagnostics.

Qiagen’s syndromic testing franchise head, Nadia Aelbrecht, emphasized the company’s unique dual approach, offering both comprehensive and targeted syndromic panels. This flexibility allows clinicians to tailor testing to specific patient needs, supporting faster and more accurate diagnoses.

Qiagen plans to submit a second gastrointestinal panel, covering five major bacterial pathogens, for FDA clearance soon. Additionally, it aims to seek approval for QIAstat-Dx Rise, a high-capacity version of its diagnostic system, later this year.

In 2024, Qiagen received FDA clearance for four QIAstat-Dx panels, including a meningitis/encephalitis panel. The company also announced the opening of a new site in Barcelona, Spain, set to become a hub for QIAstat-Dx operations. Furthermore, Qiagen obtained CE mark certification for its QIAstat-Dx system under the EU’s IVDR regulations in September 2024.