Tag: Unyvero™ P50 Pneumonia Cartridge
Company News: Curetis and Scholz Collaborate to Industrialize and Scale-Up Production of Unyvero(TM) Cartridge Plastics Parts
– German family firm ‘Scholz-HTIK – High Tech in Kunststoff’ has been selected by Curetis based on systematic benchmarking process –
Curetis AG today announced a strategic supply chain partnership with German family business Horst Scholz GmbH + Co. KG for the production of high-quality plastics parts for its Unyvero™ Cartridge.
Under the agreement, Curetis will invest more than € 2 million in multi-cavity tools for all Unyvero™ Cartridge plastics parts. Curetis has already ordered several multi-cavity tools from Scholz. The first tools will be delivered in early 2013.
Scholz has been chosen by Curetis due to its unrivalled experience and expertise in medical device-grade injection molding, its state-of-the-art facilities and equipment as well as its cleanroom manufacturing infrastructure.
Scholz has a long track record and outstanding commitment to total quality management, e.g. regarding the use of CT scanners for quality control of parts. Curetis expects a smooth transition from its previous R&D phase supplier to the serial production and scale-up run by its new partner Scholz.
Company News: Curetis Completes Enrollment for its EU Trial As Planned
– Prospective multi-center trial enrolls 800 patient samples in 7 months-
Curetis AG today announced it has completed enrollment for the European clinical trial of its Unyvero™ Pneumonia Application on schedule. More than 800 patient samples were collected until September 30, 2012. Data analysis will be completed in early 2013. Subsequently, results will be published in a major, peer-reviewed journal.
The trial will compare the performance of the Unyvero™ P50 Pneumonia Cartridge with conventional microbiology culture, the current standard of care. Primary endpoint will be clinical sensitivity and specificity for the identification of 17 pathogens covered by the Unyvero™ P50 panel. Secondary endpoints include time to result and correlation of resistance marker detection with phenotypic antibiograms. Curetis will conduct systematic discrepant results resolution by PCR and sequencing to confirm the clinical truth in samples where Unyvero results differ from microbiology culture.
The study complements the previously completed CE performance evaluation study, in which the Unyvero P50 Cartridge identified a significant number of additional pathogens not detected by microbiology culture. These findings were confirmed by PCR analysis.
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.