Product News: Molecular Diagnostic Unyvero Solution to be Launched in the Netherlands

02 Oct 2012

Curetis AG and Mediphos have closed an exclusive distribution agreement to roll-out of Curetis´ Unyvero™ Solution and the Unyvero™ P50 Pneumonia Application in the Netherlands. Mediphos is an experienced independent distributor with a clear focus on molecular diagnostics and an emphasis on microbiology-based applications. Mediphos will also be responsible for a clinical evaluation project in the Netherlands and will present the Unyvero Solution™ at the autumn meeting of the National Microbiology Association (NVVM) on November 15, 2012.

The Dutch target market for the Unyvero™ Solution covers approximately 40 hospitals (both university and large general hospitals). Significant market research has been jointly conducted by the partners to define a clear-cut execution strategy. Positive feedback from clinical opinion leaders and major hospitals has led to a two-pronged approach: while all target hospitals will be approached in parallel, the first Unyvero™ instrument system will be placed at one of the country’s leading university hospitals where a clinical evaluation by clinical opinion leaders will be initiated right away.

“This agreement is another milestone in our commercialization strategy and will further accelerate the international availability of the Unyvero solution,” said Oliver Schacht, CEO of Curetis AG. “Given the close proximity and the many similarities between our home markets and the Netherlands, we have decided to make this a strategic priority early on. We believe that Mediphos is the ideal partner, combining decades of relevant IVD and microbiology expertise and the entrepreneurial spirit and drive it takes to introduce such a totally novel platform concept.”

The CE-marked Unyvero™ System is a versatile hardware platform for the detection of a broad panel of bacteria and antibiotic resistances from a single sample in one run. It processes a disposable cartridge providing the necessary reagents to complete the analysis from sample to result.

The platform enables the DNA-based testing of all clinically relevant samples in a fully automated, unsupervised analysis process requiring only few, quick manual preparation steps. The analysis thus can be performed with minimal operator time and without the need of skilled staff or special infrastructure. Clinically relevant information is available within about four hours to support an informed therapy decision as early as possible.

The first CE-marked Unyvero™ Cartridge, Unyvero™ P50, focuses on pneumonia testing and simultaneously analyses 39 DNA targets. The second Unyvero™ application for implant & tissue infections is already in product development. Cartridges for additional indications, such as blood stream infections and tuberculosis, are in preparation.

André van der Mark, CEO of Mediphos commented: “Curetis´ Unyvero solution nicely fits into our strategic focus of growing our microbiology franchise and knowledge whereas we have a presence in almost all Dutch hospitals with some of our products. The Netherlands is one of the leaders in dealing with antibiotic resistance issues such as MRSA, but we realize that staying at the cutting edge in antibiotic resistance detection and combating its spread requires much more comprehensive approaches such as the Unyvero Pneumonia Application.”