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Company News: Curetis to Present Data from Unyvero LRT U.S. FDA Clinical Trial at ASM Microbe
– U.S. data set complemented by recent clinical study data from European hospital
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that significant clinical data updates on its Unyvero System and P55 / LRT cartridge for the diagnosis of pneumonia and lower respiratory tract infections will be presented at ASM Microbe 2017, being held June 1-5 in New Orleans, LA.
Detailed data from Curetis’ U.S. FDA clinical study of the Unyvero System and the LRT cartridge for the diagnosis of lower respiratory tract infections will be presented by Dr Matthew Sims, Director, Infectious Diseases Research at Beaumont Research Institute and one of the U.S. FDA study’s principal investigators. Dr Sims will present the study during an oral presentation titled Multicenter Evaluation of the Curetis Lower Respiratory Tract Infection Cartridge on the Unyvero-Platform in session 481, “Pneumonia: Novel Epidemiology, Novel Approaches” (June 5, 2017, 12:15-12:30 PM, Room 208).
In addition, Dr Sims will present clinical data from the portion of the study conducted at Beaumont Hospital, Royal Oak, MI. His presentation Potential Impact of Rapid Diagnostics in Management of Suspected Pneumonia, will be given in the session “Antimicrobial and Diagnostic Stewardship” (June 2, 2017, 12:45-2:45 PM, Exhibit Hall D, Exhibit and Poster Hall).
The U.S. data on the P55/LRT cartridge are complemented by recent findings of researchers at the Institute of Medical Microbiology, University Hospital Essen (Essen, Germany), who published data concluding that the “Unyvero Application is a useful diagnostic tool for the early and rapid detection of pathogens in respiratory specimens”. They reported a significantly higher detection rate when using Unyvero as compared to culture methods and a considerably reduced time-to-result, from a median of 48h to a median of 7.5 hours. The team has tested the Unyvero P55 pneumonia application cartridge in daily clinical routine with 439 respiratory specimens of 342 patients. Results from the European Study were presented during this year’s 5th Joint Conference of the DGHM & VAAM / VAAM Annual Meeting 2017 and published in Schmidt D et al., Early and Rapid Detection of Respiratory Pathogens: A Commercial Multiplex PCR Assay in Comparison with Culture. Biospektrum Abstractbook Microbiology and Infection 2017, Heidelberg 2017, p. 131 – DOI: 10.1007/s12268-017-0772-x).
“We are excited that new clinical data on our Unyvero P55 / LRT cartridges, which are in line with our findings from various CE performance evaluation studies, have been published in this peer-reviewed format,” said Johannes Bacher, COO of Curetis. “They demonstrate the performance of Unyvero in terms of sensitivity and specificity, and also confirm the substantial advantage in terms of time-to-results. Moreover, we are proud that the data from our U.S. FDA trial were selected for an oral presentation at the upcoming ASM Microbe meeting.
He added that new studies are upcoming in the U.S. and the EU to further investigate clinical benefit and impact of the Unyvero P55/LRT cartridge.