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In a release, the company noted:
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.
"We are very pleased that the results of the study indicate that the LightTouch is capable of discovering disease that may be missed by conventional cervical disease detection," said Mark L. Faupel, Ph.D., GT President and CEO at the Southeastern Medical Device Association annual conference in Atlanta. "Based on the study results, we believe that our technology also demonstrates the capability to detect cervical disease early, when it is most effectively treated."
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 company expects to complete analyzing the study results and present the findings to the FDA in the second quarter of 2009.
The GT LightTouch technology systematically 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.
According to studies published in the peer-reviewed Journal of Lower Genital Tract Disease, the non-invasive 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.
((Comments on this story may be sent to health@closeupmedia.com))
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