PredictImmune, developers of pioneering prognostic tools for guiding treatment options and improving patient outcomes in immune-mediated diseases, today announced CE IVD (European Conformity In-Vitro Diagnostic Medical Devices) certification for its prognostic biomarker test for IBD, PredictSURE IBD„¢ – the first validated biomarker based prognostic test in inflammatory disease.
Achievement of the CE mark enables PredictImmune to take the test to market across the UK and Europe and also enables development of market access to the rest of the world.
The CE mark provides quality assurance for the test, validating that the product meets the essential requirements of all relevant European Medical Device Directives and is a legal requirement to place a device on the market in the EU. This accreditation is the culmination of 18 months work to optimise the test, ensuring consistency and reproducibility after its transfer from University of Cambridge School of Medicine.
Paul Kinnon, CEO, PredictImmune commented: We are exceptionally pleased to have gained CE accreditation for PredictSURE IBD„¢. The test, which has been validated in Crohns disease and ulcerative colitis patients, independent of the discovery population, will be available in January 2019. This is the first validated biomarker based prognostic test in inflammatory disease. This milestone marks a significant step towards the provision of personalised medicine in IBD, which will have a direct and significantly positive impact on the quality of treatment and outcomes for patients.
Immune-mediated diseases, such as Crohns disease and ulcerative colitis, are chronic and incurable with clinical courses that vary among individuals with the same disease. To date, these diseases have been treated with a ˜one size fits all approach, despite there being significant variation in disease course between patients with the same disease. Currently, IBD patients are treated in one of two ways: ˜top down which uses the most aggressive form of treatment first, and ˜step up, which starts with the least aggressive form of treatment. The chosen treatment course currently depends on local guidelines. This approach means that patients with a relatively mild form of the disease tend to be over treated, resulting in significant side effects, whilst those with a more aggressive form of the disease, can be under-medicated, resulting in frequent relapses or flare-ups, which result in long term damage and significant morbidity and mortality. PredictImmunes tests give clinicians the ability to determine how aggressive a patients disease is at the point of diagnosis, enabling them to make informed decisions about the treatment course most relevant for each individual patient.
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PredictSURE IBD„¢ is a first step towards personalised medicine in IBD and an exciting development towards providing better outcomes for patients with IBD, worldwide.
For more information: www.predictimmune.com
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