Development of a Cancer Specific PCNA Tumor Marker Immu*

描述（由申请人提供）： 该一期SBIR项目将展示一种基于分子肿瘤标志物癌症特异性增殖细胞核抗原（csPCNA）的创新癌症筛查和诊断测试。一个新的紧凑型设备，csPCNA免疫传感器，将设计和构建的基础上输入的初始数据。所提出的csPCNA免疫传感器具有拯救生命的潜力， 通过更有效和更早地发现疾病，大大降低医疗保健成本。该测试可以在医生进行？的办公室或诊所。 该项目将采用三项创新技术： * 最近鉴定的肿瘤标志物csPSNA的单克隆抗体， * 一种灵敏、快速集成的波导生物传感器， * 一种利用纳米操纵的新型分析表面制备方法。 许多癌症标志物可商购获得，但大多数缺乏灵敏度和选择性。目前可用的基因测试可以指示癌症风险，但可能无法可靠地确认疾病的存在。相比之下，csPCNA已显示存在于测试的60个癌细胞中的100%中，但在正常细胞或良性肿瘤中未发现。csPCNA免疫传感器可以简化癌症筛查并降低成本，因为单个测试可以检测整个范围的肿瘤。 癌的 csPCNA免疫传感器还可以为跟踪治疗进展和缓解患者的随访监测提供预后信息。该测试将远低于磁共振成像（MRI），X射线计算机断层扫描（CT）或PET。 拟定商业应用：这种测试可用于癌症筛查和诊断，仅在美国每年就有80亿美元和45亿美元的市场。 目前，每年约有5 000万例巴氏涂片检查、3 000万例乳房X光检查、3 000万例PSA检测、2 000万例潜血检测和250万例活组织检查用于这些目的。

DESCRIPTION (provided by applicant): This Phase I SBIR project will demonstrate an innovative cancer screening and diagnostic test based on the molecular tumor marker cancer specific proliferating cell nuclear antigen (csPCNA). A new compact device, the csPCNA Immunosensor, will be designed and constructed based on input from initial data. The proposed csPCNA Immunosensor has the potential to save lives and significantly reduce health care costs through more effective and earlier detection of the disease. The test can be performed in the physician?s office or clinic. The project will incorporate three innovative technologies: * A recently identified monoclonal antibody for the tumor marker csPSNA, * A sensitive and rapid integrating waveguide biosensor, and * A novel assay surface preparation method utilizing nanomanipulation. Many cancer markers are available commercially but most lack sensitivity and selectivity. Currently available gene tests can indicate cancer risk but may not reliably confirm the presence of the disease. By contrast, csPCNA has been shown present in 100% of the 60 cancer cells tested, but has not been found in normal cells or benign tumors. The csPCNA Immunosensor can simplify cancer screening and reduce cost because a single test can detect a whole range of cancers. The csPCNA Immunosensor can also provide prognostic information for tracking treatment progress and follow-up monitoring of patients in remission. The test will be far less expensive than magnetic resonance imaging (MRI),x-raycomputed tomography (CT), or PET. PROPOSED COMMERCIAL APPLICATION: This test can be used for cancer screening and diagnosis, which are $8 billion and $4.5 billion annual markets in the U.S. alone. Currently some 50 million Pap smears, 30 million mammograms, 30 million PSA tests, 20 million occult blood tests, and 2.5 million biopsies are performed annually for these purposes.