OCTOBER 1, 2008 -- Guided Therapeutics, Inc.(Norcross, GA) has completed the U.S. Food and Drug Administration (FDA) pivotal clinical trial for its LightTouch noninvasive cervical cancer detection device. The GT LightTouch technology systematically and rapidly scans the cervix to identify cancers and precancers painlessly, noninvasively, and cost effectively by analyzing the wavelengths of light reflected from cervical tissue.
Since the pivotal trial began, approximately 1,900 women have been tested to demonstrate the technology's accuracy in detecting cervical disease, including an arm of the study that assessed effectiveness of the commercial version of the device and single-use disposable. The technology has already undergone safety evaluations by FDA and is considered to be nonsignificant risk by hospital institutional review boards.
"Our next steps are to analyze the results and to file our premarket approval application with the FDA," said Mark L. Faupel, Ph.D., GT President and CEO.
The 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.
"The LightTouch has the potential to help detect cervical disease before it becomes life threatening," said Dr. Leo B. Twiggs, Professor and Chair Ob/Gyn
University of Miami Miller School of Medicine and a principal investigator in the study. Early detection and treatment are the best ways to increase survival and preserve the reproductive health for women."
According to studies published in the peer reviewed Journal of Lower Genital Tract Disease, the LightTouch test has the potential to be significantly more accurate when compared to the Pap test and Human Papilloma Virus test, two standard tests women currently undergo for cervical screening and diagnosis.
"Based on our experience during the clinical trial, I believe that my patients
would overwhelmingly favor LightTouch over the current standard of care because it is less painful and is designed to provide an immediate result," said Dr. Marc Winter of Orange Coast Women's Center. Dr. Daniel Sternfeld of Saddleback Women's Center added, "Because LightTouch is cost effective and easy to implement in a broad range of clinical environments, it has the potential to transform how cervical disease is managed."
The LightTouch uses proprietary technology to analyze light reflected from the cervix. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the noninvasive test does not require a tissue sample or laboratory analysis, and results are available immediately. In all, nearly 3,000 women have enrolled in studies using prototypes of the noninvasive cervical cancer detection device with no instances of significant or unexpected adverse events. Research and commercialization of the device were funded, in part, by grants from the National Cancer Institute and Georgia Research Alliance.
Guided Therapeutics, Inc.