Tag: Europe

Company News: Curetis Initiates Prospective Multicenter Unyvero™ Study in Europe

– Study to demonstrate added value of Unyvero™ P50 pneumonia application in clinical routine –

Curetis AG today announced the start of an additional prospective, multicenter clinical trial of its marketed Unyvero™ P50 Pneumonia Application to demonstrate its clinical and health economic value.

The CE performance evaluation completed last year already demonstrated 81% sensitivity at 99% specificity for detecting pneumonia-causing pathogens. Following the market launch in April 2012, Curetis in 2013 presented data from more than 1,000 patient samples showing overall sensitivity of its pathogen panel of 80.6% at a specificity of 96% (ECCMID European Conference of Clinical Microbiology and Infectious Diseases, Berlin).[1]

The new multicenter study aims to establish real-world data on the health economic impact of fast, patient-near molecular testing and subsequent therapy adjustments (if necessary). It will be conducted in five leading European centers and will involve several hundred critically ill patients with pneumonia requiring mechanical ventilation. The study is designed to first evaluate the current pneumonia treatment and clinical outcome situation  by detailed chart reviews comparing patients having received initial adequate, respectively inadequate treatment. Data will be used to fine tune endpoints for the interventional, randomized second part of the study, which aims to investigate the potential clinical and economic benefit of the Unyvero™ system. Parameters analyzed will be, e.g. type of antibiotic regimen and costs, length of stay in the ICU, etc.

Participating clinicians are world-renowned intensive care, pulmonology and microbiology specialists: Prof. Manfred Quintel (University of Goettingen), Prof. Tobias Welte (MHH University Clinic Hanover), Prof.s Philippe Eggimann and Gilbert Greub (CHUV University Hospital of Lausanne), Prof. Mathias Pletz (Jena University) and Prof. Antoni Torres (University Hospital Clinic Barcelona).

Preliminary results of the study are expected by the end of this year.


[1] Abstract Nr. 2360: M. Klein et al., First clinical validation of a rapid molecular test (Unyvero™ P50 Pneumonia Application) detecting microorganisms and antibiotic resistances in patients suspected with severe pneumonia.

Food for Thought: Germany Lags Behind in Biotech

These days, everybody has his own opinion about the quality and prospects of the German biotechnology industry. It even seems to be difficult to determine if biotech funding in Germany has increased, remained stable – or dramatically decreased, as recently published by the German industry organization BIO Deutschland.

If you look at key intangibles, such as the extent of media coverage on the biotech sector and the attractiveness of German biotech companies for investment banks, it is obvious that German biotech is not on the rise.

An article by Roland Benedikter and James Giordano published by German newspaper Die Welt suggests a bleak scenario if Germany is not willing to accelerate and intensify its biotech efforts. According to the authors, biotechnology is not only the most important success factor in future economic development – it will also change the global power balance: “the one who controls the chips also controls the game”. Asia and the Far East are quickly catching up in the biotech space, while the U.S. and other European countries continue to heavily invest into the sector. Therefore, Germany might gradually evolve from an export-oriented country to an import-oriented one – unless there will be a fundamental change of mind in the German government and society.

Almost two decades ago, the German biotech industry started out with the clear goal to narrow the gap to the U.S., where biotechnological markets and ventures were (and still are) much more mature. Since then, the German biotech sector has successfully produced a number of promising companies, innovations and products. However, the most attractive and advanced companies and technologies have been acquired by foreign, mostly U.S.-based, companies. Amgen´s take-over of Micromet, an oncology company with academic roots at the University of Munich, is the most recent example.

Therefore, lack of innovation is clearly not the problem. And lack of funding is only the symptom of an underlying German (and partly European) biotech phenomenon – wide-spread risk aversion combined with limited availability of true executive leadership qualities. Moreover, the public sentiment towards biotechnological innovation remains skeptical or even hostile and is mirrored by a “we don’t need this”-attitude of politicians and even Germany’s healthcare system, in which IQWiG, a decision body responsible for drug reimbursement, does its best to belittle innovative medicines.

It may not surprise you that an often-heard German term, “technologiefeindlich” (i.e. a negative attitude towards technological innovation), lacks any English equivalents.