Women with cervical disease could have been diagnosed up to two years earlier using the Guided Therapeutics (GT) LightTouch Cervical Scanner, according to results of a US FDA pivotal clinical trial being presented at the American Society for Colposcopy and Cervical Pathology biennial meeting.
GT said that the study, which is the basis for seeking FDA approval, also indicated that nearly 40% of women without disease could have avoided potentially painful and invasive follow up exams, including biopsy.
The pivotal study examined 1,607 women who received the LightTouch test and other tests routinely used to refer women to biopsy. Included in the study were 802 women who returned for follow up visits, 68 of whom were found to have precancer and cancer missed by the current diagnostic standard of care consisting of Pap test, HPV test, colposcopy and biopsy.
Guided Therapeutics said that the current diagnostic procedures missed 38.6% of precancers and cancers in women with follow up. Of the 51 cases of precancer and cancer missed by the standard of care, LightTouch has detected 44 of these missed cases (86.3 %), some as early as two years prior to current practice procedures.
According to one of the five abstracts discussing the pivotal trial results, ‘LightTouch offers the potential of a cost effective test that provides an immediate result at the point of care while detecting significantly more moderate and high-grade dysplasia (disease) and significantly reducing the need for additional testing for benign (no disease) and CIN1 (low risk) lesions.’
Mark Faupel, president and CEO of GT, said: “We believe that these results show that our LightTouch technology can be a future factor in improving the standard of care for women’s cervical health and also significantly reduce the personal and financial burden of unnecessary follow up procedures. We also believe that having this type of painless scanning technology will remove a barrier to seeking early and preventive care and save lives by finding disease early when it is most successfully treated.”