DECEMBER 10, 2008--Guided Therapeutics Inc. (GT; Norcross, GA), which completed an FDA trial of its cervical detection devicethis fall, has now submitted the first of three modules of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA). The LightTouch non-invasive cancer screening tool which promises painless, effective differentiation between diseased and healthy cervical tissue.
The move is "a key step in gaining access to the multi-billion dollar U.S. cervical cancer detection market," said GT's president and CEO Mark L. Faupel, Ph.D. "We are now focused upon completing and submitting the Clinical and Manufacturing modules early next year."
The content and schedule for submitting the modules, which represent major sections of the entire PMA application, were agreed to in advance by GT and the FDA. The technology has already undergone safety evaluations by FDA and is considered to be non-significant risk by hospital institutional review boards.
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.
Approximately 1,900 women were tested in the PMA pivotal clinical trial to demonstrate the technology's accuracy in detecting cervical disease. In all, nearly 3,000 women have enrolled in studies using LightTouch prototypes with no instances of significant or unexpected adverse events.
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.
Research and commercialization of the device were funded, in part, by grants from the National Cancer Institute and Georgia Research Alliance. 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.
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Guided Therapeutics Inc.