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.