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Curetis to Launch Next Generation CE-IVD Unyvero Implant and Tissue Infection Application Cartridge
- ITI now covers 102 diagnostic targets, including 85 pathogens and 17 resistance markers
Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, today announced the successful completion of the CE Performance Evaluation study of the next generation of its Unyvero ITI Implant and Tissue Infection Application Cartridge (Unyvero ITI).
The new Unyvero ITI comes with an extended panel and increased sensitivity. It will be launched in the third quarter of 2016 as a CE-IVD-marked product in the European direct sales and international distribution markets. Unyvero ITI is designed for the diagnosis of many types of severe infections, including prosthetic joint infections, surgical site infections, catheter-associated infections and skin and soft tissue infections.
The next-generation cartridge now covers a total of 102 diagnostic targets: 85 of the most clinically relevant pathogenic microorganisms, including Gram positive and Gram negative bacteria, several fungi, and 17 related antibiotic resistance markers. Specifically, the next generation ITI cartridge has added a universal bacterial primer, several Candida species, various types of Streptococci, Klebsiella variicola, and other new diagnostic targets. In addition, clinical sensitivity has been significantly improved for many key pathogens. Unyvero ITI is the most comprehensive commercially available panel for this indication area in a cartridge-based sample-to-answer format. The first generation ITI Application Cartridge launched in 2014 covered a total of 80 diagnostic targets.
Sold as a consumable running on the Curetis Unyvero System, the product analyzes many challenging and heterogeneous sample types such as fluids, tissues, swabs and others. It is the second Application Cartridge for the Unyvero System launched in 2016, following the recent launch of the BCU Blood Culture Application Cartridge.
In the performance evaluation study, a total of 1,100 samples were tested with the next generation ITI Cartridge. These included 700 samples positive for microbial growth in the routine work-up of patients.
Final validation results from patient samples demonstrated
an overall sensitivity for all pathogens of 86.9% and
an overall specificity for all pathogens of 99.2%.
Several customer sites at renowned hospitals in Europe have already agreed to further evaluate the second generation Unyvero ITI product in their clinical routine.
"We are excited to start marketing the new ITI Application Cartridge for our Unyvero Platform," said Dr. Achim Plum, Chief Commercial Officer of Curetis. "Our development team has done a tremendous job and provided us with an improved, next generation product with higher clinical sensitivity overall, as well as an even broader panel. With more than 100 diagnostic targets covered by the new Unyvero ITI cartridge, we believe we have a solution with the broadest available panel for suspected implant and tissue infections and an unmatched versatility allowing the use of a wide range of routine clinical patient sample types."
Curetis' CEO Oliver Schacht, PhD, added, "A key priority for us since the IPO has been the expansion and acceleration of our product pipeline. With the successful validation and launch of the BCU product in Q2 and now the second generation ITI cartridge in Q3, we continue to deliver on key milestones of our equity story outlined at the time of our IPO."
CAUTION - Investigational device. Limited 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 available 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.
This document constitutes neither an offer to buy nor to subscribe securities and neither this document nor any part of it should form the basis of any investment decision in Curetis.
The information contained in this press release has been carefully prepared. However, Curetis bears and assumes no liability of whatever kind for the correctness and completeness of the information provided herein. Curetis does not assume an obligation of whatever kind to update or correct information contained in this press release whether as a result of new information, future events or for other reasons.
This press release includes statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes", "estimates", "anticipates", "expects", "intends", "may", "will", or "should", and include statements Curetis makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. Curetis' actual results may differ materially from those predicted by the forward-looking statements. Curetis undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
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