Preview of FDA Pivotal Clinical Trial Results Presented at National Cancer Institute Conference
Results of the FDA pivotal clinical trial for the LightTouch™ Non-invasive Cervical Cancer Detection Device conducted by Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP), indicated that the current system for diagnosing cervical disease missed the same amount of disease as a landmark study carried out by the National Cancer Institute (NCI).
In the new LightTouch study, conducted at six US clinics and with an enrollment of approximately 2,000 women, 32% of cervical precancers and cancers were missed by the current method of human papillomavirus (HPV) testing and colposcopy, while only 19% of biopsy samples indicated the presence of these diseases. Similarly, the ASCUS/LSIL Triage Study for Cervical Cancer (ALTS), sponsored by NCI, indicated that approximately 35% of disease was missed and only about 26% of biopsies found significant disease. Both ALTS and the LightTouch study used follow up data to estimate the number of missed disease cases when the original diagnosis was rendered.
“ALTS sheds new light on problems plaguing cervical disease management after a women undergoes Pap screening and adjunctive tests, such as HPV and colposcopy,” said Mark L. Faupel, Ph.D., President and CEO of GT. “Our FDA study confirms the ALTS results and shows the high rate of false positives and false negatives using conventional procedures and technology.”
The results were presented at NCI’s inaugural Investor Forum at Boston University. GT was selected as one of NCI’s top innovators. GT has been awarded approximately $6 million in six consecutive grants from the NCI to develop the new, pain-free test for detecting cervical disease.
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 technology is designed as a device employing a single-use disposable patient interface.
Organized and funded by the National Cancer Institute, ALTS included more than 5,000 women. It began in November 1996 and concluded at the end of 2000. ALTS was a clinical trial to find the best way to help women and their doctors decide what to do about the mildly abnormal and very common Pap test results known as ASCUS and LSIL. About three million women in the United States are diagnosed with ASCUS and LSIL each year.
Since development of the LightTouch began, more than 3,000 women have been tested with the LightTouch, including approximately 2,000 women who were enrolled in GT’s FDA pivotal clinical trial.
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 tissue sample-based tests such as Pap and HPV.