Curetis to Present Clinical Unyvero Data at Major Scientific Conferences
Published: Sep 04, 2013
Holzgerlingen, Germany, September 4 , 201 3 -- Curetis AG today announced the upcoming present ation of new clinical data on two Unyvero™ applications at the 53rd Interscience Conference on Antimicrobial Age nts and Chemotherapy (ICAAC 2013) in Denver, CO (Sept. 10 - 13) and at the 65 th Joint Annual Meeting of the German Society for Hygiene and Microbiology and the German Society for Infectious Diseases (DGHM /DGI 2013) in Rostock, Germany ( Sept. 22 - 25).
Curetis will introduce clinical data from a U.S. pre - FDA trial phase of its Unyvero™ LRT (Lower Respiratory Tract) infection a pplication at the ICAAC conference. The poster ‘ Evaluation of a Molecular Multiplex Test For Detection of Respiratory Microorganism and An tibiotic Resistance Genes in Clinical Specimens ’ * will present data generated at Northwestern Memorial Hospital (Chicago, IL) during the initi al familiarization and training phase for the FDA trial . The FDA trial is now being conducted at four sites; all c linical data are blinded until completion of this ongoing trial which is expected for 2014 . The LRT application is already marketed and branded outside the U.S. as the Unyvero™ P50 pneumonia application. During ICAAC , Curetis will also showcase its Unyvero ™ S olution at booth no. 822 in the exhibition hall.
Moreover , Curetis will present data of its novel Unyvero™ i60 ITI application for the diagnosis of implant and tissue infection s detecting pathogens and resistance markers at the annual DGHM /DGI meeting . The poster presentation ‘ A new Multiplex PCR - Panel for the Detection of Pathogens Related to Implant and Tissue Infection ’ † will introduce the panel chosen for the diagnosis of eight indication areas and present initial validation and verification data wit h clinical samples. Curetis will also host the industry symposium ‘ Imp l ant and Tissue Infections - A Diagn o s tic Challenge ’ (Sept. 24, 12:15 - 1:15pm, Auditorium 2 ) featuring talks and case studies by Prof . Petra Gastmeier (Berlin, Germany), Dr. Anne Thews (H olzgerlingen, Germany) , Prof. Andrej Trampuz (Berlin, Germany), and Dr . Oliv i er Borens (Lausanne, Switzerland). A second poster based on data independently generated at the University Hospital in Basel, Switzerland will present a ‘ Comparison of the Unyvero ™ Pneumonia P50 Assay with standard culture and antimicrobial susceptibility testing ’ .
“We are very happy that we can provide further data on the clinical value of our applications and the progress of our pipeline , ” said Oliver Schacht, CEO of Curetis. “ I n fall this year, we will start a clinical CE evaluation study of the i60 ITI application , which we have been developing in close collaboration with our strategic development and commercialization partner Heraeus Medical . We are expecting the launch and ma rketing roll - out for early 2014. ”
Schacht added that Curetis has already started development efforts towards a third application. “We will provide an update at upcoming investor meeting s in autumn , ” he said.
CAUTION - Investigational device. Lim ited by Federal (or United States) law to investigational use. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on the Curetis Unyvero™ technology is currently avai lable for sale in the United States of America or Canada. The analytical and clinical performance characteristics of any Curetis Unyvero™ product which may be sold at some future point in time in the U.S. have not yet been established.
About the Unyver o™ System
The CE - marked Unyvero ™ System is a versatile hardware platform for the detection of a broad panel of bacteria , fungi and antibiotic resistances from a single sample in one run. It processes a disposable cartridge providing the necessary reagents to complete the analysis from sample to result. It is marketed in Europe, Russia, the Middle E ast and various other non - European countries. In the U . S . , Curetis is running a prospective multi - center clinical trial aimed at achieving FDA clearance registere d under www.ClinTrials.gov NCT01922024.
The platform enables the DNA - based testing of all clinically relevant samples in a fully automated, unsupervised analysis process requiring only few, quick manual preparatio n steps. The analysis thus can be performed with minimal operator time and without the need of skilled staff or special infrastructure.
Thereby, clinically relevant information is available within about four hours to support an informed therapy decision as early as possible.
The first CE - marked Unyvero™ Cartridge, Unyvero™ P50, focuses on pneumonia testing and simultaneously analyses 39 DNA targets. The second Unyvero™ application for implant & tissue infections is in late - stage product development. Cartrid ges for additional indications, such as blood stream infections and tuberculosis, are in preparation.
About Curetis AG
Founded in 2007, Curetis AG is a molecular diagnostics company which focuses on the development and commercialization of reliable, fast and cost - effective products for diagnosing severe infectious diseases. The diagnostic solutions of Curetis AG enable rapid multi - parameter pathogen and antibiotic resistance detection in only a few hours, a process that today can take up to days or even we eks with other techniques.
To date, Curetis has raised total funds of over € 49 . 1 million (~ USD 65 million). The company is based in Holzgerlingen near Stuttgart, Germany. Curetis has signed collaboration agreements with Heraeus Medical, Sanofi Pasteur an d Cempra Inc. as well as several international distribution agreements.
Curetis AG Max - Eyth - Str. 42
71088 Holzgerlingen, Germany
Tel. +49 7031 49195 - 10
Dr. Ludger Wess / Ines - Regina Buth
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68
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