Yahoo Finance

By Brian Marckx, CFA & Anita Dushyanth, PhD OTC:BLGTY

A large unmet need exists in the U.S. and Europe for non-invasive screening of bladder cancer. Studies have shown the incidence/mortality rates as well as the costs associated with the disease detection to be high. The company (BLGTY) reported successful results from their blinded, multi-center clinical study using the CellDetect technology for detecting bladder cancer. The primary endpoint of effectively detecting the recurrence of bladder cancer in subjects with a history of the disease was achieved. The need to detect bladder cancer noninvasively is large and the CellDetect technology has shown 84.4% sensitivity and specificity of 82.7% in detection of cancerous cells in clinical studies. The sensitivity performance of three other noninvasive tests to detect the recurrence of bladder cancer currently in the market are urine cytology test (50%), BTA stat (68.8%) and NMP22 BladderCheck (17.4%). Today, BioLight announced that the European Patent Office has issued a patent for the CellDetect technology that will be in effect until March 2027. The company also announced that the CellDetect non-invasive test for detecting bladder cancer in urine has obtained CE Mark thus enabling commercialization in the European Union. Obtaining the CE Mark for the CellDetect technology to detect the recurrence of bladder cancer represents a significant milestone and achievement for BioLight. The company is now focused on building awareness of the product to facilitate broader roll-out in Europe using distribution agreements in CE Mark territories. The company may use the CE Mark as a stepping-stone to submit a Pre-IDE application for CellDetect to the U.S. FDA sometime during the first half of 2016. …TeaRx… In February 2015, the company reported clinical study findings that identified positive statistical correlations between the TeaRx multi-parameter diagnostic test and widely used benchmark tests for dry eye syndrome (DES). The process of defining the reliable combination of parameters that are required for the DES diagnostic kit is underway. In mid-June 2015, BioLight announced their collaboration with Ora Inc., a world-leading independent, full-service ophthalmic contract research organization (CRO) and product development firm, to aid in the commercial development of TeaRx. The two companies have agreed to fund the clinical study and other activities required to obtain U.S. 510K regulatory approval for TeaRx as well as to incorporate the test kit in other clinical trials sponsored by third parties and performed by Ora.SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR and to view our disclaimer.