CE Mark Allows ProAxsis to Begin Commercialisation in Europe
Commenting on the news, Fran?ois R. Martelet, Chairman of ProAxsis and Chief Executive Officer of NetScientific, said: "We are delighted that ProAxsis has achieved a significant milestone in successfully CE marking its novel ProteaseTag® Active Neutrophil Elastase Immunoassay for chronic respiratory diseases. This will help accelerate its commercialisation in the COPD and Cystic Fibrosis markets.
"ProAxsis is now able to sell its immunoassay in the 28 member states of the European Union, as well as Switzerland, Turkey, Iceland, Norway and Liechtenstein. Achieving CE Mark for its immunoassay demonstrates the Company's clear commitment to delivering first-class quality products to physicians and their patients who suffer from chronic respiratory diseases."Commenting on the news, Dr David Ribeiro, CEO of ProAxsis, said: "This is a very proud day for everyone at ProAxsis, with the successful registration of our first CE Mark. We have already had enquiries from a number of pharmaceutical companies concerning the commercial use of our ProteaseTag® Active Neutrophil Elastase Immunoassay in their upcoming clinical trials, and look forward to making the assay more widely available to the respiratory community now that it has its CE Mark. I would particularly like to acknowledge the work of Dr Charlene Robb, who has led the regulatory efforts that have enabled us to reach this significant milestone."
ProAxsis is developing a range of products for the capture, detection and measurement of active protease biomarkers of diseases. This test measures Neutrophil Elastase, a leading indicator of infection in patients with Cystic Fibrosis (CF) and Chronic Obstructive Pulmonary Disease (COPD) and an important drug target. The rapid and easy-to-use tests incorporate patented ProteaseTags®; smart molecules which trap an active protease within a complex biological sample and enable a visual readout of its presence. ProteaseTags® provide a unique tool to identify and quantify active protease biomarkers and will assist in the clinical validation of new therapeutics.