Tag: CE-marking
Company News: Curetis Prepares Launch of Second Unyvero™ Application
– Final clinical performance evaluation study for Unyvero™ i60 ITI application ongoing
– Study data expected by the end of Q1/2014
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has completed development of its second Unyvero™ application. The new Unyvero™ i60 ITI cartridge rapidly identifies more than 90 pathogens and more than 20 resistance markers common in implant and tissue infections. After successfully manufacturing several lots and completing initial verification testing of the cartridge, the Company has initiated a pivotal study using approximately 500 cartridges to validate analytical, technical and clinical performance for CE marking.
Following the completion of the study scheduled for end of Q1/2014, commercialization of the Unyvero™ i60 ITI is expected to begin in Q2/2014. Curetis will jointly market the cartridge with Heraeus Medical GmbH, the development and commercialization partner for this cartridge. Both companies have already received pre-orders from key opinion leaders and hospitals across central Europe.
The study will use frozen patient specimens – watery/swabs, viscous/purulent, sonication and synovial fluids, and biopsy material – for diagnosis. The study will compare the molecular test with conventional microbial culture techniques. Discrepant or unexpected results will be resolved by additional tests. The study will also test assay repeatability and reproducibility and establish limit of detection.
Company News: Curetis AG Signs Up BioLine LLC as Exclusive Distribution Partner for Russia
– Partners to start registration process and market launch in Russia –
Curetis today announced that it has signed up BioLine LLC as an exclusive distribution partner for Russia, Ukraine, Kazakhstan and Belorus. BioLine is a major player in these markets and distributor for global companies such as Becton Dickinson, Leica Microsystems and many others.
BioLine is preparing the registration of the Unyvero™ Solution and the Unyvero™ P50 Pneumonia Application with the Russian Ministry of Health for regulatory clearance to sell the CE-marked IVD in Russia.
There is a huge unmet medical need for better pneumonia diagnostics in the region. According to the WHO, 1.5 million cases of pneumonia occur in Russia each year, of which only about 0.3 to 0.4 million are registered with the authorities. 25-33% of patients experience prolonged duration due to antibiotic resistances. Diagnosis is still poor: it is estimated that 20% of all patients diagnosed with severe flu in Russia are in fact suffering from pneumonia. Mortality from pneumonia is huge, reaching 14-20% in the elderly (≥ 60 years) and up to 25% in young children.
Company News: Curetis AG Chooses Mediphos as Exclusive Distribution Partner for the Netherlands
– Partners prepare market launch and clinical evaluation project –
Holzgerlingen, Germany, September 26, 2012 — Curetis AG today announced that Curetis and Mediphos have closed an exclusive distribution agreement for the Netherlands. Mediphos is an experienced independent distributor with a clear focus on molecular diagnostics and an emphasis on microbiology-based applications.
Under the agreement, both companies will prepare the market roll-out of Curetis´ Unyvero™ Solution and the Unyvero™ P50 Pneumonia Application. Moreover, Mediphos will 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.
Company News: Curetis AG Signs Distribution Deal in Middle East with ATC
– Kuwait Ministry of Health clears Unyvero™ Solution for clinical evaluation –
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that it has signed an exclusive distribution deal for its Unyvero™ solution with Advanced Technology Company K.S.C. (ATC). ATC will become the exclusive distributor of the Unyvero Solution including consumables for the six Gulf Cooperation Council (GCC) countries and the Lebanon.
Placement of instruments will start in the third quarter this year. A clinical evaluation project of the Unyvero™ Solution has been approved by the Kuwait Ministry of Health and will take place at leading clinical sites in the country. Curetis, ATC and the clinical investigators will cooperate closely during this phase, and are planning to publish evaluation data in 2013 at a renowned international medical conference.