...will die CE Mark im Q4 2016 haben.
Scheint wohl deren Strategie zu sein, sich erstmal um den EU Markt zu kümmern, wollen Epi in USA aus dem Weg gehen.
Dennoch Taapken hat ja immer gesagt, wie schwer der EU Markt ist: heterogen, keine einheitlichen CRC Richtlinien, Ärzte Verdienen nichts an der Blutabnahme, etc...
Bin gespannt auf die große US Studie. Die guten Performance Zahlen - was erst noch zu beweisen wäre... Epi hatte in der kleinen EU Studie für CE Mark auch Sensitivität und Spezifität von über 80 und 90%
Dennoch interessant was so der Wettbewerb macht. Bis FDA Zulassung von NuQ ist es noch ein langer steiniger Weg... Meine Schätzung: nicht vor 2020
NAMUR, Belgium, Sept. 6, 2016 /PRNewswire/ -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing diagnostic tests for cancer, today announced that it expects to receive CE Marking on its Nu.Q Triage Colorectal Cancer Screening Test (blood test) in late 2016 and aims to begin marketing the test commencing in early 2017. The test, developed at Volition's laboratories in Belgium in conjunction with Hvidovre Hospital, University of Copenhagen, has demonstrated the potential to reduce colonoscopies by 25% while maintaining almost 97% detection of colorectal cancer. Data supporting the test results will be presented at the forthcoming European Society for Medical Oncology Conference in October 2016. Volition plans initially to focus its launch of the test in the EU member states, which have an aggregate screening age population of approximately 148 million persons.
The most frequently used first line screening test for colorectal cancer across Europe is the faecal immunochemical test (FIT). Patients with a positive score following FIT tests are then referred for colonoscopy. However, 94.8% of people who test positive with FIT do not have colorectal cancer. i This means there are a significant number of unnecessary expensive and invasive colonoscopies performed, placing a severe burden on both the patient and the healthcare system. For countries utilizing the Nu.Q test, patients with a positive FIT score could subsequently be given the blood-based Nu.Q Triage Colorectal Cancer Screening Test and then only be referred for colonoscopy if the combined test results indicate that it is necessary, thus potentially reducing colonoscopy referrals by 25%.
Speaking about the planned launch, Cameron Reynolds, CEO of Volition said, "Offering European healthcare systems a simple and easy to use blood test which can be used to triage FIT positive populations for colorectal cancer is very exciting as we are coming to market with something that potentially meets a pressing need in many European countries. After much market analysis, we believe that commercializing this product, a single normalized assay, is the quickest way to achieve significant revenue for our proprietary Nucleosomics® platform."
While screening program uptake varies across Europe, European Guidelines for Quality Assurance in Colorectal Cancer Screening and Diagnosisii are in place. These guidelines aim to assist Member States in their national screening programs for colorectal cancer and, therefore, provide a target audience for whom colorectal cancer screening is very much on the agenda.
Colorectal cancer is ranked second among all newly-diagnosed cancers and responsible for approximately 215,000 deaths in Europe each year.iii Early diagnosis is crucial as approximately 97% of bowel cancer patients caught at stage I will have an average five year survival rate and most will be cured, while if caught at stage IV the average survival rates fall to 7%.iv However, of the 41,500 patients diagnosed with bowel cancer in the U.K. each year, only a very small proportion of these are diagnosed with stage I disease (16% of men and 14% of women).v As well as the increased rate of mortality with late diagnosis, there are also significant cost implications as treating late stage disease is often more costly than treating patients with early stage disease.
There are organized colorectal cancer screening programs in 14 of the 28 EU states with a further 10 states offering some form of public or privately accessible screening.
Berkeley Greenwood, Managing Director of Decideum, Volition's market access advisor said: "While colorectal cancer screening programs across Europe have been shown to be successful, they are creating a number of pressure points within healthcare systems, particularly in terms of colonoscopy capacity. In the U.K., for example, colonoscopy referral times can exceed 14 weeks. The introduction of Nu.Q to help physicians decide whether patients need to go on to have a colonoscopy has significant opportunity to alleviate some of these capacity pressures and to ensure resources are focused on those individuals who really need it."
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