CellDetect non-invasive test recieves CE mark approval in EU for bladder cancer recurrence- BioLight Life Sciences

The CellDetect non-invasive test, from BioLight Life Sciences, for detecting bladder cancer in urine has obtained CE Marking, enabling the product to be marketed and sold in Europe and other territories. BioLight also announced that the European Patent Office has issued a patent related to the core of the CellDetect technology. The patent will be in effect until March 2027.

In 2015, a blinded, multi-center clinical study of the CellDetect non-invasive test for detecting recurrence of bladder cancer in urine, successfully achieved the study's primary endpoint for effectively detecting the recurrence of bladder cancer in subjects with a history of the disease. The CellDetect bladder cancer test successfully identified cancerous cells in urine samples in patients with a history of the disease, with reported sensitivity of 84.4% and specificity of 82.7% for the study's primary endpoint. Micromedic plans to submit a Pre-IDE for the Product to the FDA in H1/2016.