Guided Therapeutics, Inc. (GT) announced that the LightTouch non-invasive cervical cancer detection technology properly identified cervical disease missed by Pap tests and conventional pathology in a multi-site FDA pivotal clinical trial. Based on the outcome of the study, GT plans to submit the trial results to the FDA as part of the Premarket Approval (PMA) application for the LightTouch. The company expects to complete analyzing the study results and present the findings to the FDA in the second quarter of 2009. Since the pivotal trial began, more than 1,900 women were tested to demonstrate the technology’s safety and efficacy in detecting cervical disease, including an arm of the study that assessed effectiveness of an investigational commercial version of the device and single-use disposable. The study protocol indicated that all subjects were referred after undergoing a Pap test, or had some other risk factor that fulfilled the referral criteria of the study. Each subject was tested with the LightTouch investigational device and underwent an additional Pap test, colposcopic exam and biopsy. Two generations of the investigational LightTouch were used in the trial. Preliminary results from the study showed that the LightTouch performed better than the Pap test. The investigational commercial version of the LightTouch detected approximately 46 percent more cervical disease than the Pap test – a statistically significant improvement. The GT LightTouch technology systematically and rapidly scans the cervix to identify cancer and pre-cancer painlessly and non-invasively by analyzing the wavelengths of light reflected from cervical tissue. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the LightTouch test does not require a tissue sample or laboratory analysis, and is designed to provide results immediately. Clinical trial sites include the University of Miami, The University of Texas Southwest, Emory University/Grady Memorial Hospital in Atlanta, the Medical College of Georgia in Augusta, GA, St. Francis Hospital/University of Connecticut in Hartford, Orange Coast Women’s Center and Saddleback Women’s Center in California.