Development of a Cancer Specific PCNA Tumor Marker Immu*

描述(由申请人提供)： 这个第一阶段的SBIR项目将展示一种创新的癌症筛查和诊断测试，该测试基于分子肿瘤标记物癌症特异性增殖细胞核抗原(CsPCNA)。根据初始数据的输入，将设计和建造一种新的紧凑型设备--csPCNA免疫传感器。建议的csPCNA免疫传感器有可能拯救生命和 通过更有效和更早地发现疾病，显著降低医疗保健成本。该检测可在S医生办公室或诊所进行。 该项目将采用三项创新技术： *最近发现的针对肿瘤标记物csPSNA的单抗， *灵敏和快速集成的波导式生物传感器，以及 *一种利用纳米操纵的新的化验表面制备方法。 许多癌症标记物可以在商业上买到，但大多数缺乏敏感性和选择性。目前可用的基因测试可以表明癌症风险，但可能不能可靠地确认疾病的存在。相比之下，csPCNA在60个被测试的癌细胞中100%存在，但在正常细胞或良性肿瘤中没有发现。CsPCNA免疫传感器可以简化癌症筛查并降低成本，因为一次测试就可以检测到一系列 癌症。 CsPCNA免疫传感器还可以为追踪治疗进展和对缓解期患者的随访监测提供预后信息。这项测试将比磁共振成像(MRI)、X射线计算机断层扫描(CT)或PET便宜得多。 拟议的商业应用：这种测试可以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5000万次巴氏涂片、3000万次乳房X光检查、3000万次PSA检查、2000万次隐血检查和250万次活组织检查。

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.