Therapy Areas: Oncology
New QIAstat-Dx Gastrointestinal Panel Demonstrates Excellent Performance in Multicenter Clinical Study in Europe, According to Study
19 August 2019 - - Dutch sample and assay technologies company Qiagen (NYSE: QGEN) has published a multicenter clinical study demonstrating the accuracy of its QIAstat-Dx syndromic testing solution for diagnosing the causes of acute gastroenteritis, the company said.

The QIAstat-Dx Gastrointestinal Panel delivered high performance compared to other, existing multiplex tests in this study which evaluated 385 patient samples at university hospital laboratories across Europe.

The study showed the QIAstat-Dx Gastrointestinal Panel was highly sensitive (98.2% positive % agreement, a measure of ability to detect pathogens) and specific (99.9% negative % agreement, a measure of ability to identify true negative samples).

Multiple pathogens were identified in nearly one-third of the patient samples that tested positive. Authors emphasised the system's "ease of use" and that the system and assay yielded results in approximately one hour.

The study also cited the ability of the QIAstat-Dx panel to provide cycle threshold values and amplification curves, quantitative indications of the amount of nucleic acids detected, as a unique advantage in interpreting diagnostic findings for gastrointestinal syndromes, which can be complicated by co-infections or false positives in testing.

These are important capabilities which other currently widely used syndromic platforms do not offer.

The article, "Multicenter evaluation of the new QIAstat Gastrointestinal Panel for the rapid syndromic testing of acute gastroenteritis," has been accepted for publication by the European Journal of Clinical Microbiology and Infectious Diseases (EJCMID) and is available online.

The study was conducted at Copenhagen University Hospital Hvidovre in Denmark and University Hospital of Bonn in Germany.

Introduced in Europe in early 2018 and the United States in mid-2019, the QIAstat-Dx system enables fast, cost-effective and easy-to-use syndromic testing with novel Sample to Insight solutions.

The QIAstat-Dx Gastrointestinal Panel provides differential detection of more than 20 bacterial, viral and parasitic pathogens implicated in gut infections. The panel is already available in Europe. The QIAstat-Dx Respiratory Panel, for detection of more than 20 common viral and bacterial infections in respiratory syndromes, is currently available in Europe and the United States.

Qiagen is developing a pipeline of planned assays for the QIAstat-Dx content menu, spanning infectious diseases, oncology, companion diagnostics and other disease areas.

Qiagen N.V., a Netherlands-based holding company, 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. Automation solutions tie these together in seamless and cost-effective workflows.

Qiagen provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R and D and industrial applications, primarily forensics).

As of June 30, 2019, Qiagen employed approximately 5,200 people in over 35 locations worldwide.


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