VOLUME MICROPROBE TM ASSISTED BLADDER BIOPSY

约4万例早期移行细胞新发病例 癌症(TCCA)每年在美国出现。超过3万人是 浅表；75%复发；10-15%进展为侵袭。监视 患者一生中都需要进行膀胱镜检查(约600,000 每年进行膀胱镜检查)。 早期扁平TCCA常常难以捉摸，通常需要6个月。 对医生选择的部位进行随机活组织检查。《中谱》 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路上皮 最终，为分期和分级提供客观帮助。它的用法 将导致更早发现隐匿性TCCA，降低 进展为浸润性病变，每次膀胱镜活检可能减半。 每年的医疗费用将减少约3100万英镑。如果 每次膀胱镜活检较少允许在局部检查下进行更多膀胱镜检查 在办公室里麻醉，每年可以节省500美元 百万美元。主要的医疗好处：减少了 尿细胞学异常的表现及诊断和治疗 复发的TCCA对无疾病可能产生积极影响 生死存亡。 我们将制作一个膀胱探头，对30名患者进行测量 与既往诊断为膀胱TCCA的患者进行比较，并对结果进行分析 确定膀胱癌探针法能在多大程度上区分恶性 非恶性尿路上皮，如果它能显著更好地做到这一点 而不是泌尿科医生的眼睛。 建议的商业应用：每次活检250美元，少两次 每次检查的活检每年将节省超过3亿美元。 如果更少的活检允许更多地使用局部膀胱镜检查 在办公室里麻醉，每年可以节省1.9美元 十亿美元。

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.