Tag: molecular diagnostics

Company News: Curetis AG Achieves CE-Marking for Unyvero™ Solution and Initiates Commercialization

– Successful completion of performance evaluation study; CE Mark for Unyvero™ instrument system and pneumonia application

Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that the company has achieved the CE marking for its Unyvero™ suite of instruments and the P50 Pneumonia Cartridge and that is has already initiated national and international commercialization activities. The performance evaluation of Curetis´ Unyvero™ System and the Unyvero™ P50 Pneumonia cartridge was successfully completed just recently.

The evaluation has demonstrated excellent performance characteristics of the Unyvero™ pneumonia application in terms of sensitivity and specificity. Overall sensitivity in 186 tested fresh and frozen clinical sputum, aspirate and lavage samples was above 75% sensitivity with a better than 95% specificity. The Unyvero™ P50 pneumonia application cartridge identified 74 additional pathogens missed by standard microbiology culture, which was used as gold-standard comparator in terms of performance. If confirmed with independent methods this might demonstrate that the Unyvero™ pneumonia test offers significant improvements in terms of sensitivity over current clinical standards. This analysis is ongoing.

Cartridge and instrument system have also passed other important criteria, such as repeatability, reproducibility, interference testing, and cross-reactivity. The complete performance evaluation study included 318 Unyvero™ P50 cartridge runs between January and April 2012.

Based on positive feedback from many potential distribution partners during the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) earlier this year, Curetis has also begun establishing its international distributor network and expects to target an even broader international market than originally anticipated beginning in 2012/13 already.

Company News: Curetis AG Successfully Increases Series A Round to EUR 24.5 Million

Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced an extension of its Series A financing, bringing the total size of the round to € 24.5 million. CD-Venture joined the funding as a new investor, while all of Curetis’ existing VC investors participated in the round. Several private investors also continued to co-invest.

Following the appointment of Oliver Schacht, PhD, as the new CEO of Curetis last month, this financing transaction is the first step towards funding next year’s commercial launch and roll-out of the Unyvero product platform together with the first CE marked IVD test cartridge for pneumonia and antibiotic resistances in Europe. The additional funds will allow Curetis to pursue a more aggressive strategy towards initiating a US clinical trial in H2-2011 with a goal of filing for FDA approval in 2012. This Series A financing positions Curetis as a solidly funded molecular diagnostics company with near-term commercial-stage products and its unique platform solution addressing a clear unmet medical need in the rapid diagnosis of infectious diseases and antibiotic resistance.

Curetis’ CEO Oliver Schacht will present an update on the company at the upcoming BioEquity 2011 in Paris. The presentation is scheduled for May 23, 2011, at 5:00 pm CET, Room Pont de Sully.

Further details can be found here.


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