PredictImmune is gearing up to launch its novel prognostic test for inflammatory disease after it was awarded a CE mark.
Acquisition of the CE mark enables PredictImmune to market PredictSURE IBD, now the first validated biomarker based prognostic test in inflammatory disease, across the UK and Europe, whilst also enabling development of market access to the rest of the world.
To date, immune-mediated diseases such as Crohn’s disease and ulcerative colitis have been treated with a ‘one size fits all’ approach, despite there being significant variation in disease course between patients with the same disease.
These chronic and incurable diseases are currently 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, meaning the patients don’t always get the most appropriate form of treatment for their case.
Possession of the CE mark indicates significant progress towards improving treatment and outcomes for IBD patients in the UK and Europe, the firm noted.
“We are exceptionally pleased to have gained CE accreditation for PredictSURE IBD,” said Paul Kinnon, chief executive of PredictImmune.
“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.”
The test, which has been validated in Crohn’s disease and ulcerative colitis patients, independent of the discovery population, will be available in January 2019.