Tag: molecular diagnostics

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 and Heraeus Medical Collaborate on the Development of New Unyvero™ Diagnostic Cartridge

– Joint development of cartridge for orthopaedics, wound and surgery infections –

Curetis AG and Heraeus Medical GmbH have signed a collaboration agreement to jointly develop a novel Unyvero™ cartridge for the detection of pathogens and antibiotic resistances in implant & tissue infections (ITI). One key application area will be in orthopaedics, e.g. to diagnose infections after knee and hip replacement surgeries.

Under the terms of the agreement, Heraeus and Curetis will co-fund product development in the respective indication areas. Heraeus’ customers will be given access to the Unyvero™ solution, while Curetis will pay a sales commission for any customer referrals by Heraeus to Curetis. No licenses are involved and further financial details were not disclosed.

Curetis will retain full control over its commercialization strategy and execution both directly in the DACH region as well as via its international distributor network. The resulting Unyvero cartridge and application will be a Curetis-labeled IVD.

The collaboration will provide Heraeus with access to leading-edge, innovative and easy-to-use in vitro diagnostics and molecular diagnostic solutions for its customers. The new ITI cartridge will be of interest not only in general surgery, but also in infections caused by biofilms (e.g. on knee and hip implants or catheters), in abdominal surgery infections, diabetic foot, burn wounds etc.

Today, wound and surgical site infections are increasingly caused by bacteria carrying multiple antibiotic resistances. In orthopaedic indications, infections often involve biofilms, communities of microorganisms very hard to open up and cultivate. At present, it may take 7-15 days to obtain results from biofilm samples. This scenario often leads to prolonged empiric treatment, follow-on surgeries and increased morbidity and healthcare costs.

For the development of the new cartridge, the partners have jointly conducted market research in orthopaedic applications throughout Europe. They have also teamed up with clinical key opinion leaders in Germany, Switzerland, France, the UK, and Scandinavia to determine the pathogens and antibiotic resistances that need to be included in the diagnostic panel of the new cartridge. The partners expect assay development for the new cartridge to be completed by early 2013, with clinical validation and CE marking throughout 2013 and an expected launch in the EU by the end of 2013. The product is likely to include more than 40 and possibly up to 50 analytes.

Curetis will present its Unyvero™ solution at the 64th Annual Meeting of the German Society for Hygiene and Microbiology (DGHM) in Hamburg (September 30 – October 3, 2012).

Company News: Curetis AG and Cempra, Inc. Collaborate on the Detection of Community-Acquired Bacterial Pneumonia Pathogens

– Cempra to use Curetis’ Unyvero™ solution in its Phase III trial of its antibiotic solithromycin (CEM-101) –

Curetis AG and Cempra Inc. (NASDAQ: CEMP) today announced a research and development collaboration to incorporate Curetis’ Unyvero™ molecular diagnostic system into Cempra’s upcoming global Phase 3 trial of the oral formulation of solithromycin in patients with community-acquired bacterial pneumonia (CABP).

Under the terms of the agreement, each party may use the generated data for its own product development and for its regulatory filings.

Cempra’s randomized, double-blind Phase 3 trial comparing solithromycin against a comparator drug is expected to enroll over 800 patients in more than 100 clinical sites worldwide. Sputum samples from patients will be sent to Curetis for analysis with its Unyvero™ Solution and the CE-marked Unyvero™ P50 Pneumonia Application Cartridge. Molecular diagnostic data generated from the Unyvero™ Solution will be paired with clinical and traditional microbiology data to enhance the pathogen diagnosis rate in the trial. The trial is expected to start during the fourth quarter of 2012 and enrollment is expected to be completed in 2014.


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.

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