BioLight receives CE Mark approval for CellDetect bladder cancer test

BioLight Life Sciences Investments Ltd. (OTC: BLGTY, TASE:BOLT), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that its CellDetect® non-invasive test for detecting bladder cancer in urine has obtained CE Marking, enabling the product to be marketed and sold in Europe and other territories. The CE marking recognizes the conformity of the CellDetect® non-invasive test for detecting recurrence of bladder cancer in urine with the relevant directive of the European Community. 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.

The CellDetect^® technology is being developed by Micromedic Technologies (TASE: MCTC), BioLight's cancer diagnostics subsidiary, and allows an accurate diagnosis of cancerous and precancerous cells, based on a unique combination of color and morphology, by utilizing a proprietary kit containing unique extract and dyes.

Earlier this year, 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 U.S. Food and Drug Administration in H1/2016.

"This CE Mark approval for the CellDetect® bladder cancer test represents an important commercial milestone," said BioLight's Chief Executive Officer, Suzana Nahum Zilberberg. "Of the estimated 430,000 new cases of bladder cancer occurring worldwide in 2012, approximately 151,000, or 35%, were in Europe according to Cancer Research UK. There is a clear and urgent need for improved diagnostics in this important market, and we believe the CellDetect® technology answers that call, as well as the potential for diagnosing additional cancer indications."