Qiagen received FDA clearance for its new QIAstat-Dx mini gastrointestinal panel last week.
According to Qiagen, the test is the first in a series of QIAstat-Dx gastrointestinal (GI) panel tests for clinical use.
The new QIAstat-Dx Gastrointestinal Panel 2 mini B&V (bacterial and viral) is designed for the rapid outpatient diagnosis of gastrointestinal conditions.
The GI panel is designed to identify an array of bacterial, viral and parasitic pathogens responsible for gastrointestinal infections. These infections are common and can result in severe complications if not diagnosed and treated promptly.
Along with Norovirus, one of the most common causes of gastrointestinal infection and an important target during the winter season, the test covers a total of five common causes of gastrointestinal illness as recommended by the Infectious Diseases Society of America (IDSA) — the bacteria Campylobacter, Salmonella, Shiga-like toxin E.Coli (STEC) and Shigella.
The panel’s ability to detect multiple pathogens in a single test will greatly enhance clinical decision-making, ensuring that patients receive appropriate and timely treatment.
Qiagen has a larger 16-target version of the mini panel, the QIAstat-Dx Gastrointestinal Panel 2, which is useful for evaluating hospitalized patients with risk factors for severe disease.
The QIAstat-Dx gastrointestinal mini panels are more targeted, offering “a streamlined approach for diagnosing the most actionable pathogens causing gastrointestinal infections,” says Qiagen.
Related: New HCV Test Enables Diagnosis and Treatment in a Single Visit
According to the press release from Qiagen, in the US, there are over 179 million estimated cases of acute infectious gastroenteritis per year, which is a leading cause of outpatient visits and hospitalizations.
In 2024, Qiagen received FDA clearance for four QIAstat-Dx panels designed for critical respiratory testing needs for both inpatient and outpatient settings, along with diagnostics for gastrointestinal infections, meningitis and encephalitis.
This included the QIAstat-Dx meningitis/encephalitis panel for diagnosing central nervous system infections, which received FDA clearance in November 2024.
The QIAstat-Dx panel is the first to receive US regulatory clearance in 2025.
XTALKS WEBINAR: Unlocking Efficiency and Compliance in Clinical Diagnostics
Live and On-Demand: Tuesday, February 04, 2025, at 2pm EST (7pm GMT/UK)
Register for this free webinar to learn how laboratory information management systems (LIMS) are purpose-built to meet the exacting demands of today’s clinical diagnostics labs.
Qiagen says it plans to submit another two GI panels for clearance in early 2025. One of them covers five of the most common bacterial pathogens that cause gastrointestinal infections: Campylobacter, Salmonella, STEC, Shigella and Yersinia enterocolitica.
The other is the QIAstat-Dx Rise, a higher-capacity version of its diagnostic instrument.
The QIAstat-Dx Gastrointestinal Panel 2 Mini B&V uses QIAstat-Dx’s real-time PCR technology to rapidly amplify multiple genetic targets within a single reaction. This enables results to be delivered in approximately one hour, with less than one minute of hands-on preparation required, according to Qiagen.
Additionally, cycle threshold (Ct) values and amplification curves offer laboratories valuable insights into potential co-infections, which can be instantly viewed on the instrument’s touchscreen without the need for extra software.
“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, in the press release.
“Our range of panels enables healthcare professionals to tailor testing to their specific needs, ensuring fast and accurate diagnosis while supporting better treatment decisions.”
If you want your company to be featured on Xtalks.com, please email [email protected].
Join or login to leave a comment
JOIN LOGIN