Tag: benefits

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: Are We Really the Prey? Nanotechnology as Science and Science Fiction

In his 2002 novel Prey, Michael Crichton develops a scary scenario about the impact of “molecular manufacturing”, i.e. the convergence of nanotechnology, biotechnology, and information & communication technologies. The concept focuses on the risks of self-replicating, so-called  “nanoscale assemblers” and was originally published by scientists K. Eric Drexler (former co-founder of the Foresight Institute) and Richard Feynman. Criticized and challenged by fellow scientists such as Nobel Prize winner Richard Smalley, the concept of molecular manufacturing nevertheless reflects society´s fear of novel, unknown technologies – specifically, the fear of losing control over some seemingly overwhelming artificial power.

In their paper “Are We Really the Prey? Nanotechnology as Science and Science Fiction“, Australian scientists Diana M. Bowman, Graeme A. Hodge, and Peter Binks have analyzed the impact, chances and risks of the molecular manufacturing concept. Calling not only for improving the regulatory framework on novel technologies such as nanotechnology, their key conclusion is that “unwillingness to engage in public dialogue is a consumer and citizen backlash waiting to happen, as was experienced with biotechnology. Current real developments in nanotechnology offer exciting opportunities to advance the human condition; however, implausible ideas framed by some scientists only serve to influence the creative talents of science fiction writers, like Crichton, who then prey on the public’s lack of knowledge of the current boundaries of nanotechnology for entertainment’s sake.”

Consequently, the advancement of innovative products does not only call for more adequate regulatory conditions, but also – and most importantly – for the willingness and proactivity of both the scientific community and innovation-driven companies to increasingly address and interact with the general public. As it has turned out, the acceptance of innovative technologies by the public may be the crucial key to success or failure.

Source:  “Are We Really the Prey? Nanotechnology as Science and Science Fiction”, by Diana M. Bowman, Graeme A. Hodge and Peter Binks, Bulletin of Science Technology Society 2007; 27; 435. An online version of the paper is available here