METHYLATION SPECIFIC PCR FOR CANCER DIAGNOSIS/PROGNOSIS

用于癌症诊断/预后的甲基化特异性 PCR

• 批准号: 6294798
• 负责人: ROBERT W VELTRI
• 金额: $ 9.76万
• 依托单位: UROCOR, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-06-01 至 2001-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6294798
• 关键词: biopsy; diagnosis design /evaluation; gene expression; human tissue; in situ hybridization; methylation; neoplasm /cancer diagnosis; nucleic acid amplification techniques; polymerase chain reaction; prognosis; prostate neoplasms; technology /technique development

APPLICANT?S DESCRIPTION: UroCor, Inc., seeks to develop and optimize the technology of gene specific hypermethylation detection and determine the feasibiity of delivering diagnostic and/or prognostic methylation assays to the marketplace. The recognition that aberrant gene methylation plays an important role in carcinogenesis has increased in recent years. The number of genes known to undergo hypermethylation and the role of hypermethylation gene silencing in cancer has also increased. The recent development of rapid and sensitive technology for the detection of DNA methylation have made the possibility of clinically informative assays attractive. The Specific Aims for this Phase I proposal are: Specific Aim I: Development of solution-phase Methylation Specific PCR to amplify and detect methylated target genes in isolated genomic DNA. Specific Aim II: Development of Methylation Specific PCR-in situ hybridization for use on prostate needle core biopsy sections. Specific Aim III: Comparison of solution-phase Methylation Specific PCR to Methylation Specific PCR-in situ hybridization using prostate needle core biopsies. This research will also allow the creation of defined assay protocols for use in the potential Phase II SBIR of this project, the determination of clinical utility of these assays with large, prospective, multicenter IRB-approved clinical trials. PROPOSED COMMERCIAL APPLICATION: This proposal will determine the feasibility of using methylation detection assays in the clinical laboratory. More than a quarter million Americans are expected to be diagnosed with prostate, bladder or kidney cancer. If the average unit re-imbursement is approximately $100, the above population represents $25 million in annual revenue, assuming only one test per patient, and no tests to monitor the course of the disease. UroCor, Inc. has the sales and marketing ability to deliver such a test to the urologic community.

申请人？S描述：UroCor，Inc.，致力于开发和优化 基因特异性甲基化检测技术 将诊断性和/或预后性甲基化测定递送至患者的可行性 市场。认识到异常的基因甲基化在 近年来，在致癌作用中的作用有所增加。已知的基因数量 以及高甲基化基因沉默在 癌症也增加了。快速灵敏的 检测DNA甲基化的技术使得 临床信息分析吸引人。第一阶段的具体目标 具体目标I：开发液相甲基化 特异性PCR扩增和检测分离基因组中甲基化的目的基因 DNA.具体目标II：开发甲基化特异性PCR-原位 用于前列腺针芯活检切片的杂交。具体目标 III：液相甲基化特异性PCR与甲基化特异性PCR的比较 使用前列腺针芯活检的特异性PCR原位杂交。这 研究还将允许创建定义的测定方案， 该项目的潜在II期SBIR，确定临床实用性 在这些试验中，具有大型、前瞻性、多中心IRB批准的临床试验 审判 拟定商业应用： 该提案将确定在临床实验室中使用甲基化检测测定的可行性。 预计将有超过25万美国人被诊断出患有前列腺癌、膀胱癌或肾癌。 如果平均单位报销额约为100美元，则上述人群的年收入为2 500万美元，假设每个患者仅进行一次检测，并且没有检测来监测疾病的进程。 UroCor公司具有向泌尿科社区提供这种测试的销售和营销能力。