Research Project
8133463
DESCRIPTION (provided by applicant): Guided Therapeutics has developed the LightTouch(R), a non invasive, point of care device that uses a combination of fluorescence and reflectance spectroscopy to measure the entire ecto-cervix in an imaging format. Our test is intended for use prior to colposcopy by a trained healthcare professional (e.g., physician, nurse practitioner, physician's assistant) to triage women found to have an intermediate Pap result to identify those women who have high grade disease. It could also be used to triage young women in whom HPV testing is not beneficial and where HPV infection rates may be as high as 80% regardless of whether dysplasia is present. In addition to identifying high grade disease, the LightTouch device can provide enhanced imaging that could help locate the disease on the cervix for guided biopsy and for treatment. We are applying for a Bridge Award in order to complete the final work required to bring LightTouch(R) through the FDA approval process, and begin production of a commercial device which incorporates the spectroscopic based cancer diagnostic system with high-definition imaging and mapping technologies to aid the physician in image-guided therapy. PUBLIC HEALTH RELEVANCE: LightTouch is a light-based, non-invasive and point-of-care technology that can be used to detect high grade cervical cancer in women. New guidelines issued by the American Society for Colposcopists and Cervical Pathologists (ASCCP) to categorize the likelihood of a woman having cancer indicate a need for new technology to detect high grade dysplasia (cancer), especially in younger women, women with positive HPV test results, and women with Pap smear results of ASC (Atypical Squamous Cells) as part of a more effective triage strategy. LightTouch can identify the actual existence of high grade dysplasia thereby shortening the time for treatment and follow-up for healthy women, increasing screening effectiveness, and pre-selecting those patients that need to be seen by a colposcopist more urgently for the treatment of dysplasia.
