Tag: Curetis

Company News: New Favorable Clinical Evaluation Data for Unyvero™ P50 Pneumonia Application

Dutch study demonstrates excellent sensitivity of Unyvero™ cartridges –

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced positive clinical data from an independent study conducted by researchers from the Department of Medical Microbiology of Maastricht University Medical Center (MUMC), Maastricht, the Netherlands. The data demonstrate the high clinical sensitivity of the Unyvero™ P50 Pneumonia application in detecting pathogens, including samples with low pathogen concentrations.

The researchers compared the performance of the Unyvero™ P50 cartridge with conventional microbiology culture in broncho-alveolar lavage fluid (BALF) samples for the diagnosis of ventilator-associated pneumonia (VAP), a common complication in intensive care patients. The most frequent causes are Pseudomonas aeruginosa, Staphylococcus aureus and Enterobacteriaceae.

Using the quantitative culture standard, Unyvero™ P50 Pneumonia correctly detected 8 different important pathogens in all VAP samples (n=44) at 100% sensitivity. The overall sensitivity of the Unyvero™ P50 panel was 88.6% at clinically relevant pathogen concentration. Unyvero™ P50 was also able to detect 8 different clinically relevant pathogens in 12 patient samples where conventional microbiology culture failed. This data confirms previous results where Unyvero™ had consistently detected pathogens missed by conventional culture.

The data were presented at the Scientific Spring Meeting of the Koninklijke Nederlandse Vereniging voor Microbiologie (Royal Dutch Society for Microbiology) KNVM and Nederlandse Vereniging voor Medische Milieukunde (Dutch Association for Environmental Medicine) NVMM 2014 in Arnhem, The Netherlands.

Company News: Curetis Obtains Key Patent for Unyvero™ Technology

–      Australian patent office grants patent for integrated amplification and detection in Unyvero™ cartridges

–      Patent covers unique combination of end-point PCR with array-based detection

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has been granted a core technology patent by IP Australia, the Australian patent office, for its Unyvero™ platform technology. The patent, “Reaction Vessel For PCR Device and Method of Performing PCR,” is the first of several core technology patents filed by Curetis. Its claims cover PCR chamber vessels allowing the integrated amplification and detection of DNA sequences. Curetis has submitted patent applications covering this technology in other key regions, including Europe, the U.S. and Japan. The Company expects these additional patents to be granted in the near future.

Further patents covering additional aspects of the Unyvero™ Solution, e.g. the unique sample lysis technology, are pending.

Company News: Curetis and Laboratorios LETI Sign Exclusive Distribution Agreement for Unyvero™ in Spain and Portugal

Five-year agreement based on extensive health economic assessment –

Curetis AG today announced that the company has closed an exclusive distribution agreement in Spain and Portugal with Laboratorios LETI, which includes all existing and future Unyvero™ instruments and consumables. LETI is a biopharmaceutical company based in Tres Cantos, near Madrid, Spain. Its diagnostics business unit distributes and markets a broad portfolio of in vitro diagnostics (IVD) and research products, among other offerings.

The agreement, effective January 1, 2014, was finalized following positive market feedback and favorable outcome of a joint, extensive health economic assessment which included four major hospitals in Spain and Portugal. The commercial launch of Unyvero™ in this region is expected in the first quarter of 2014.

For the implementation, Curetis will provide Unyvero training, marketing materials and supporting health economic research. LETI will manage all marketing and sales activities as well as storage and logistics support. The partners are targeting a market share of more than 50 percent of relevant hospitals and ICU units in the region within the next five years.

Company News: Curetis and Mediphos to Sponsor Expert Discussion on the Future of Infectious Diseases Testing

Satellite symposium will be held during the 8th European Meeting on Molecular Diagnostics (EMMD)

Presentation of Curetis´ Unyvero™ system by distribution partner Mediphos

Curetis AG today announced it will host the satellite symposium “Molecular microbiology – the future of infectious diseases testing?” together with its Dutch distribution partner Mediphos Medical Supplies during the upcoming 8th European Meeting on Molecular Diagnostics (EMMD). The EMDD will be held from October 2 – 4, 2013, in Scheveningen, The Netherlands.

The symposium, which is scheduled for Oct. 2 from 8:30-10am (Adama Zijlstra Rooms 1 & 2), will be chaired by Prof. Paul Savelkoul (Maastricht University, The Netherlands) and Dr. Anne Thews (Curetis, Germany). Following an overview on the expectations for the future of molecular biology by Prof. Savekoul, three lectures will discuss challenges and applications: Dr. Eric Claas (LUMC Leiden, the Netherlands) is to talk about “Benefits and challenges of molecular testing in infectious diseases”. Dr. Jan Weile (Heart and Diabetes Center Bad Oeynhausen, Germany) will present “First clinical experience with the Unyvero™ P50 Pneumonia Application” and Dr. Anne Thews (Medical Director, Curetis AG) is going to discuss “Implant and tissue infections – a need for multiplexed testing?”. The subsequent panel discussion will focus on the question whether fast molecular infectious disease testing will improve patient outcome.

In addition, Mediphos Medical Supplies, the exclusive distribution partner of Curetis for The Netherlands, will present Curetis´ Unyvero™ System during the EMMD.

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