Germany's Curetis said this week that it has begun an additional, prospective, multicenter clinical trial of its Unyvero P50 Pneumonia test to demonstrate its clinical and health economic value.
The Unyvero P50 Pneumonia assay simultaneously analyzes 39 DNA targets. The cartridge-based test runs on the Unyvero Analyzer, an inexpensive, automated, benchtop, nucleic acid molecular testing platform that combines a proprietary universal sample prep method with endpoint PCR and array-based detection.
Last year the company conducted a clinical trial for Unyvero P50 in support of CE marking, which the company achieved in May 2012 (PCR Insider, 5/17/2013). That evaluation demonstrated 81 percent sensitivity and 99 percent specificity for detecting pneumonia-causing pathogens. Also, at April's European Conference of Clinical Microbiology and Infectious Diseases in Berlin, Curetis presented data from more than 1,000 patient samples demonstrating overall sensitivity of 80.6 percent and specificity of 96 percent.
The new multicenter study aims to establish real-world data on the health economic impact of fast, near-patient molecular testing and subsequent therapy adjustments, Curetis said. It will be conducted in five European centers and will involve several hundred critically ill patients with pneumonia requiring mechanical ventilation.
Participating centers include the University of Göttingen, Hanover Medical School University Clinic, University Hospital of Lausanne, Jena University, and University Hospital Clinic Barcelona.
Curetis said that it expects to have preliminary results from the trial by the end of this year.
Unyvero P50 Pneumonia is Curetis' first CE-marked assay. The company is also developing Unyvero cartridges for additional indications such as bloodstream infections and tuberculosis.