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news.Guided Therapeutics, a medical technology company, has said that its 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.
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Based on the outcome of the study, Guided Therapeutics (GT) plans to submit the trial results to the FDA as part of the premarket approval (PMA) application for LightTouch.
The study protocol has 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% 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.
According to the company, 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, the company said.
Mark Faupel, president and CEO of GT, said: 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.