Tag: Unyvero product platform
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the start of a prospective clinical trial of its Unyvero™ System and the Unyvero™ P50 Pneumonia Cartridge in the European Union.
The prospective, international, multicenter trial will enroll up to 1,000 hospitalized patients suspected with a lower respiratory tract infection. Patient samples such as sputa, aspirates or bronchial lavages will be pre-processed by the Unyvero™ Lysator and transferred to the Unyvero™ P50 Pneumonia cartridge, which is analyzed by the Unyvero™ Analyzer.
Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to today’s diagnostics standard of care, microbiology culture. Trial sites include the University Hospital Tuebingen, Germany, the Heart and Diabetes Center Bad Oeynhausen, Germany, the Hospital Clinic of Barcelona in Spain, the Erasme Hospital in Brussels/Belgium, and the University Hospital Jena, Germany. Principal investigator is Prof. Dr. Ingo B. Autenrieth of the University Hospital Tuebingen. Interim topline data are expected for spring 2012.
Curetis AG’s latest closing of its series A financing round, which now amounts to a total of €34.1 million, has garnered the attention of many media – in particular, as Roche Venture Funds and Forbion were attracted as new investors.
“With Roche Venture Funds now on board, Curetis may have a leg up in wooing parent company Roche as a commercial partner,” comments Ben Butkus in PCR Insider. Oliver Schacht, CEO of Curetis, is quoted as saying that Roche’s investment came with “no strings attached”, adding that “it is a great sign of validation that, after a lot of due diligence and looking at … our first product, that the PCR multiplexing capabilities that we bring to complex infectious diseases has convinced them, and they made the investment.” Butkus also goes into detail on the technology of Curetis AG’s Unyvero™ System and the roll-out plans for Europe and the US.
The news was also taken up by many other media, including articles in Bloomberg/Businessweek, Dowjones Venturewire, MedNous, Genetic Engineering & Biotechnology News, Genome Web, Tornado Insider, IVDT Insight, and transkript – just to name a few.
Already in July, Susanne Kutter had featured Curetis in Europe’s biggest German-language business magazine Wirtschaftswoche in an article on hygiene deficits in German hospitals. In the article, Ingo Autenrieth, Medical Director of the University of Tuebingen’s Institute for Medical Microbiology and Hygiene, underlined that the very important advantage of the Unyvero System is its ability to quickly not only identify a disease-causing pathogen but also the antibiotic resistance genes it carries.
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the opening of its state-of-the-art production facility for disposable Unyvero™ cartridges in Bodelshausen (near Tuebingen, Germany).
The fully automated manufacturing line in a clean room environment is designed to be fully cGMP compliant and offers scalability and flexibility to meet the growing demands of clinical trials and commercialization with the scheduled 2012 EU launch of the Unyvero P50™ pneumonia cartridge.
Initial production capacity is 100,000 p.a. which may be easily expanded to an annual production capacity of 1 mio. cartridges. First product is the Unyvero™ P50 pneumonia cartridge for the identification of 17 pneumonia pathogens and 22 of their clinically most relevant antibiotic resistance markers.
Read more on the Curetis website.
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced an extension of its Series A financing, bringing the total size of the round to € 24.5 million. CD-Venture joined the funding as a new investor, while all of Curetis’ existing VC investors participated in the round. Several private investors also continued to co-invest.
Following the appointment of Oliver Schacht, PhD, as the new CEO of Curetis last month, this financing transaction is the first step towards funding next year’s commercial launch and roll-out of the Unyvero product platform together with the first CE marked IVD test cartridge for pneumonia and antibiotic resistances in Europe. The additional funds will allow Curetis to pursue a more aggressive strategy towards initiating a US clinical trial in H2-2011 with a goal of filing for FDA approval in 2012. This Series A financing positions Curetis as a solidly funded molecular diagnostics company with near-term commercial-stage products and its unique platform solution addressing a clear unmet medical need in the rapid diagnosis of infectious diseases and antibiotic resistance.
Curetis’ CEO Oliver Schacht will present an update on the company at the upcoming BioEquity 2011 in Paris. The presentation is scheduled for May 23, 2011, at 5:00 pm CET, Room Pont de Sully.
Further details can be found here.