Curetis to Launch CE-IVD Unyvero Blood Culture Application Cartridge at ECCMID 2016

Successful completion of CE Performance Evaluation Study / Covers 103 diagnostic targets with 87 pathogens and 16 resistance markers

(PresseBox) ( Amsterdam, the Netherlands and Holzgerlingen, Germany, )
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 new Unyvero BCU Blood Culture Application Cartridge (Unyvero BCU). Unyvero BCU, which will be launched in early April as a CE-IVD-marked product, is designed for the diagnosis of infections spreading through the bloodstream. The cartridge is compatible with most standard blood culture systems. Its comprehensive assay panel covers a broad range of diagnostic targets including 87 of the the clinically most relevant pathogenic microorganisms, among them Gram positive and Gram negative bacteria, several fungi and atypical pathogens, as well as 16 related antibiotic resistance markers. Sold as a consumable for Curetis' Unyvero System, the product analyzes samples from blood culture bottles inoculated with blood or punctates from patients with suspected bloodstream infections that were flagged positive for microbial growth during incubation in an automated blood culture system. It is the third Application Cartridge for the Unyvero System following the P55 Pneumonia Application launched in 2015 and the ITI Application for implant and tissue infections launched in 2014.

In the performance evaluation study, a total of 609 samples were tested with the BCU Cartridge. These include more than 200 samples from blood culture bottles flagged positive for microbial growth in the routine work-up of patients, blood cultures that were flagged negative in clinical routine as well as 59 additional blood culture bottles inoculated with one of the different microbial strains covered by the panel.

The results demonstrated

an average sensitivity for all pathogens of 96.2%,
an average specificity of 99.4%,
a positive predictive value of 90.1% and
a negative predictive value of 99.8%.

To ensure compatibility with commonly used blood culture systems, the two most common systems and bottle types in the industry by Becton Dickinson and bioMérieux were used in the study and performance has been uniformly positive across the range of systems and bottles tested. Moreover, Curetis has demonstrated that other blood culture systems and bottles such as products by Oxoid, Thermo and VersaTREK can also be used with the Unyvero BCU cartridge.

The Unyvero BCU Blood Culture Application Cartridge will be launched during the 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Amsterdam, The Netherlands (April 8-12, 2016). Three customer sites at renowned hospitals in Austria and Germany have already agreed to further evaluate the CE-IVD-marked Unyvero BCU product in clinical routine. Following the launch, Curetis expects to roll out the product via its direct selling markets in Europe and its distribution partner network in other European countries, the Middle East and Asia.

"We are excited to start marketing the third Application Cartridge for our Unyvero Platform," said Dr. Achim Plum, Chief Commercial Officer of Curetis. "With over 100 diagnostic targets covered by the Unyvero BCU cartridge, we believe to have the broadest available panel for suspected blood stream infections that can be used with a wide range of routine blood culture systems. The new Unyvero application will provide physicians with timely, comprehensive and actionable information in situations where every hour counts for the patient."

Curetis' CEO Oliver Schacht, PhD, added: "One of our key priorities after the IPO has been the expansion and acceleration of our product development pipeline. With the successful validation and launch of the BCU product, significant progress with a second generation ITI cartridge, the upcoming IAI Intra-Abdominal Application Cartridge and our Sepsis Host Response program, we continue to deliver on key aspects of our equity story outlined to the market at 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.

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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.

According to §§ 190 ff. German Reorganization Act (UmwG) and by way of enrolment in the commercial register at district court Stuttgart on March 15, 2016 Curetis plc (AG) changed its legal form into Curetis Ltd. (GmbH).
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