Curetis AG Achieves CE-Marking for Unyvero Solution and Initiates Commercialization
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 significantimprovements 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.
“We are very happy that the Unyvero System successfully demonstrated its high sensitivity, specificity and reliability using real-world clinical patient samples,” said Oliver Schacht, CEO of Curetis AG. “The CE mark is a major corporate milestone for Curetis and prerequisite for our commercialization activities in Europa and in many other countries around the globe that accept CE marking for IVDs. Our commercial team, which we have built in the preceding months, has already started direct marketing of the Unyvero System to hospitals in Germany, Austria and Switzerland.”
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.