A New Marker for Colon Cancer Screening

描述（由申请人提供）： 取代目前用于CRC筛查的FOBT（粪便隐血试验）， 50岁以上的人患结肠直肠癌。我们发现， 结肠肿瘤中TAA mRNA的表达。我们已经生产了单克隆 抗体和亲和纯化的抗血清，并已使用 这些在微孔板中形成了原型夹心酶免疫测定法 格式.我们已经用这种方法检测了70份粪便标本和一些 结肠冲洗的病人，其中肿瘤随后被发现。 头对头比较两种不同的粪便潜血试验（FOBT）， 原型夹心测定法已经证明了上级临床诊断 表演给双方。已经开始组装2500块样板， 证明标记物在相关人群中的效用。第一阶段 目的是1）产生针对TAA的额外单克隆抗体; 2） 从人类肿瘤标本中完成TAA的克隆和测序。的 我们看到的产品是一种低成本的一步免疫测定装置，适用于 在筛查模式下使用，其中检测结果呈阳性的患者将 通过乙状结肠镜或结肠镜检查。 拟议的商业应用： 用粪便中发现的TAA的免疫测定取代目前用于CRC筛查的FOBT（粪便隐血试验）。一个成功的产品将超过一倍的数字 检测到目前未检测到的癌前病变，并将假阳性的数量减少3至5倍或更多。

DESCRIPTION (provided by applicant): Replace the current FOBT (fecal occult-blood tests) used in CRC screening for colorectal cancer in individuals over age 50. We have shown upregulation of TAA mRNA expression in colon tumors. We have produced monoclonal antibodies and affinity purified antisera to the TAA and have used these to formulate a prototype sandwich enzyme immunoassay in a microplate format. We have used this assay to test 70 stool specimens and a number of colonic washes from patients in which a tumor was subsequently found. In a head-to-head comparison with two different fecal occult blood tests (FOBT), the prototype sandwich assay has demonstrated superior clinical diagnostic performance to both. Work has begun on assembling two, 500 specimen panels to demonstrate utility of the marker in relevant populations. Additional Phase I objectives are to 1) generate additional monoclonal antibodies to the TAA; 2) complete cloning and sequencing of the TAA from human tumor specimens. The product we visualize is a low cost, one-step immunoassay device suitable for use in a screening mode in which patients with a positive test result would be worked up by sigmoidoscopy or colonoscopy. PROPOSED COMMERCIAL APPLICATIONS: Replace the current FOBT ( fecal occult-blood tests) used in CRC screening with an immunoassay for a TAA found in stool. A successful product will more than double the number of cancers detected, detect pre-cancerous lesions not currently detected, and cut the number of false-positives by 3 to 5 fold or more.