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 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.
