CAP-PAP TEST FOR CERVICAL CANCER SCREENING 2

用于宫颈癌筛查的 CAP-PAP 测试 2

• 批准号: 6403076
• 负责人: OLIVERA MARKOVIC
• 金额: $ 30.62万
• 依托单位: BIOSCICON, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-05-15 至 2003-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6403076
• 关键词: acid phosphatase; biomarker; cervical /vaginal smear; cervix neoplasms; clinical research; cytodiagnosis; diagnosis design /evaluation; enzyme activity; female; human subject; neoplasm /cancer diagnosis

DESCRIPTION (provided by applicant): CAP-PAP Test (further: CPT) is a double-staining, single-slide method for cervical cancer primary screening based on a new biological marker of cervical dysplasia (US patent No. 6,143,512 of November 7, 2000). In phase-1 study (SBIR-NCI-NIH award No. 1R43CA86767-01) the method was established as a research service in a cytopathology laboratory (infrastructure: space, equipment, personnel trained for marker processing, staining and interpretation). A clinical laboratory trial (BSC-9902) began to study the accuracy of CPT in comparison with Pap test (adjudicated cytology standard) in a low-risk population of women recruited at clinical sites. After 200 analyses, in comparison with a historical control (Pap test), CPR was shown to increase perception of cytotechnicians performing primary screening and that this increased ability can result in a reduction of false negatives and an increase of true positives (ASCUS and above). After the method feasibility is confirmed, we are proposing this phase-2 project "CAP-PAP Test for Cervical Cancer Screening" to study, on 1,800 healthy women (three clinical sites), the efficacy of CPT in comparison with Pap test (clinical outcome standard) to predict occurrence and/or progress of cervical cancer or precancerosis. The goal is to bring to public benefit a screening test that could improve accuracy of Pap test, save many lives and reduce the cost of healthcare. Successful completion of phase-2 study will warrant entering a commercialization in phase-3, The test is lowcost (approximately $1.00 above the current cost of Pap test), consumer friendly (one day training), and accurate (internal control) The new marker is complementary (not competitive) to other technologies that have been recently developed to improve technical weaknesses of the conventional Pap test. If successful, CPT could face a market of 80 million requests per year. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

描述（由申请人提供）：CAP-PAP测试（进一步：CPT）是一个 宫颈癌主要筛查的双染色单斜线方法 基于宫颈发育不良的新生物学标记（美国专利6,143,512 2000年11月7日）。在第1阶段研究中（SBIR-NCI-NIH奖1R43CA86767-01） 该方法是作为细胞病理学实验室的研究服务建立的 （基础设施：空间，设备，经过标记处理的人员， 染色和解释）。临床实验室试验（BSC-9902）开始 研究CPT与PAP检验的准确性（裁决细胞学 标准）在临床部位招募的低风险妇女中。后 与历史控制（PAP测试）相比，200分析显示了CPR 为了增加对进行主要筛查的细胞技术者的看法， 这种提高的能力会导致虚假负面因素减少 真正的积极因素（Ascus及以上）的增加。方法可行性之后 确认，我们提出了这个2阶段项目“宫颈上的帽盖测试 癌症筛查“研究1,800名健康女性（三个临床部位）， 与PAP检验（临床结果标准）相比，CPT的功效 预测宫颈癌或预糖类前病的发生和/或进展。这 目标是使公众利益筛查测试，以提高准确性 在PAP测试中，挽救许多生命并降低医疗保健成本。 成功完成第二阶段研究将保证进入 在第3阶段的商业化，测试为低成本（大约高于$ 1.00 PAP测试的当前费用），消费者友好（有一天的培训）和 准确（内部控制）新标记是互补的（不竞争） 对于最近开发以改善技术的其他技术 常规子宫颈抹片测试的弱点。如果成功，CPT可能会面对市场 每年8000万要求。 拟议的商业应用程序：不可用