VOLUME MICROPROBE TM ASSISTED BLADDER BIOPSY

约40，000例新的早期移行细胞病例 肺癌（TCCA）每年在美国出现。 超过30，000人 浅表; 75%复发; 10-15%进展为浸润。 监控 膀胱镜检查是需要在病人的一生（约600，000 每年进行膀胱镜检查）。 早期平坦TCCA经常是隐匿性的，通常需要6 医生选择的部位的随机活检。 关于MediSpectra 膀胱镜分光光度计（CystoProbe）将检查这些部位 并区分肿瘤性和非肿瘤性尿道炎， 最终为分期和分级提供客观帮助。 其使用 将导致早期识别隐匿性TCCA，降低 进展为浸润，并且每次膀胱镜检查可能有一半的活检。 每年的医疗费用将减少约3100万美元。 如果 每次膀胱镜检查较少的活组织检查允许更多的膀胱镜检查， 在办公室环境中进行麻醉，每年可节省> 500美元 万 主要的医疗益处：减少了 尿细胞学异常的表现及诊治 复发性TCCA可能对无病 生存 我们将制作一个膀胱探针，对30名患者进行测量 与膀胱TCCA的既往诊断，并分析结果， 确定CystoProbe在多大程度上可以区分恶性肿瘤和 非恶性泌尿系统肿瘤，如果它可以做这一点显着更好， 泌尿科医生的眼睛 建议的商业应用：每次活检250美元，减少两次 每次检查的活组织检查每年将节省3亿多美元。 如果较少的活检允许更多地使用膀胱镜， 麻醉在办公室设置，每年节省可达1.9美元 亿

Approximately 40,000 new cases of early stage transitional cell carcinoma (TCCA) present annually in the US. Over 30,000 are superficial; 75% recur; 10-15% progress to invasion. Surveillance cystoscopies are required over the patient's lifetime (about 600,000 cystoscopies annually). Early stage flat TCCA is frequently occult, routinely requiring 6 random biopsies of physician-selected sites. The MediSpectra cystoscopic spectrophotometer (CystoProbe) will examine these sites and differentiate neoplastic from non-neoplastic urothelium, and eventually, provide objective aid for staging and grading. Its use will result in earlier identification of occult TCCA, lowering progression to invasion and might half the biopsies per cystoscopy. Annual medical care costs would be reduced by about 31 million. If fewer biopsies per cystoscopy permit more cystoscopy under topical anesthesia in an office setting, annual saving could amount to >$500 million. The major medical benefits: decreased lagtime between appearance of abnormal urine cytology and the diagnosis and treatment of recurrent TCCA with possible positive impact on disease-free survival. We will fabricate a CystoProbe, perform measurements on 30 patients with previous diagnosis of bladder TCCA, and analyze the results to determine how well the CystoProbe can differentiate malignant from non-malignant urothelium and if it can do this significantly better than the urologist's eye. PROPOSED COMMERCIAL APPLICATION: At $250 per biopsy, two fewer biopsies per examination would save more than $300 million annually. If fewer biopsies permit greater use of cystoscopy under topical anesthesia in an office setting, annual saving could amount to $1.9 billion.