Guided Therapeutics LightTouch Cervical Scanner increased detection of disease over pap tests in women seen in a busy private practice setting, according to results of a USFDA pivotal clinical trial presented at the American Society for Colposcopy and Cervical Pathology biennial meeting.
The study, which is the basis for seeking FDA approval, enrolled 1,607 subjects in a multi-center trial, including two private practice California women’s clinical centers. Data from a subset of 320 women was analyzed after being evaluated using a smaller, lower-cost commercial prototype.
In the subgroup, LightTouch increased detection of disease by 56% over the Pap, according to a presentation authored by Dr Marc Winter of the Orange Coast Women’s Medical Group and Dr Daniel Sternfeld of the Saddleback Women’s Medical Group, both of Laguna Hills, CA.
Mark Faupel, president and CEO of GT, said: “The purpose of engaging two large private practices in the study was to gain real-world experience with our technology and improve its potential for performance in the private office setting. We believe that the results indicate that our technology has the potential to improve the efficiency of the private office by detecting disease earlier and eliminating unnecessary follow up testing.
“According to the presentation of the pivotal trial results, LightTouch offers the potential of a cost effective and efficient modality for earlier detection of CIN2+ disease in women at risk for cervical disease, while at the same time reducing the number of colposcopies, biopsies and other invasive surgical procedures currently performed on normal and benign cervices.”