Economic Spectroscopic Evaluation of Cervical Cancer

描述(申请人提供)：Guided Treeutics公司开发了LightTouch(R)，这是一种非侵入性的护理点设备，它结合使用荧光和反射光谱来以成像形式测量整个宫颈外。我们的测试旨在由训练有素的医疗保健专业人员(例如，医生、护士、医生助理)在阴道镜检查之前使用，以对被发现具有中等巴氏试验结果的妇女进行分类，以识别那些患有高度疾病的妇女。它还可用于对HPV检测无益且HPV感染率可能高达80%的年轻女性进行分流，无论是否存在异型增生。除了识别高级别疾病外，LightTouch设备还可以提供增强的成像功能，帮助定位宫颈上的疾病，以便进行引导活检和治疗。我们正在申请桥梁奖，以完成使LightTouch(R)通过FDA批准程序所需的最后工作，并开始生产一种商业设备，该设备将基于光谱的癌症诊断系统与高清晰度成像和绘图技术相结合，以帮助医生进行图像引导治疗。 与公共健康相关：LightTouch是一种基于光的、非侵入性的护理点技术，可用于检测女性高级别宫颈癌。美国镜和宫颈病理学家协会(ASCCP)发布的对女性癌症可能性进行分类的新指南表明，需要新技术来检测高度不典型增生(癌症)，特别是在年轻女性、HPV检测结果阳性的女性和ASC(非典型鳞状细胞)巴氏涂片结果的女性中，作为更有效的分诊策略的一部分。LightTouch可以识别高级别异型增生的实际存在，从而缩短健康女性的治疗和随访时间，提高筛查效率，并预先选择那些更迫切需要镜检查的患者进行异型增生的治疗。

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.