Clinical and Analytical Validation of Cancer Biomarkers

描述(由申请人提供)：约翰霍普金斯医疗机构(JHMI)的生物标记物参考实验室(BRL)将作为生物标记物临床和实验室验证的网络资源，其中包括技术开发、检测标准化和方法改进。JHMI临床实验室是1988年临床实验室改进修正案(CLIA)的认证，可用于检查用于诊断、预防或治疗任何疾病的人体样本。基于我们在临床化学、免疫分析、质量控制、标准化、自动化、蛋白质组学和癌症生物标记物方面20年的经验，我们拥有开发、优化、放大和自动化诊断分析的独特能力。如有需要，我们会就试剂成分的发展和扩大规模，征询诊断行业的意见或与他们签订合约。我们已经建立了一个广泛的学术和行业合作者网络。在过去的20年里，我们成功地在癌症生物标记物和/或自动化免疫分析系统领域成功地进行了50多个由行业资助的研究项目，包括开发、验证和临床研究，最终获得了食品和药物管理局(FDA)的批准。此外，我们有兴趣开展一项开发研究，以改进验证研究的技术，包括生物信息学、蛋白质表征和生物标记物的多路复用。我们建议的技术包括免疫分析，如ELISA，蛋白质芯片，如SELDI技术，层析，如高效液相色谱和用于蛋白质表征的质谱学。我们建议成立一个由工业界和学术界领导人组成的科学咨询小组，就与新的癌症生物标记物的开发和验证有关的具体问题提供专家建议。专家咨询小组包括临床肿瘤学家、泌尿科医生、癌症生物学家、分子和解剖病理学家以及诊断行业科学家。我们相信，这种多学科方法为临床使用的癌症生物标记物的识别、验证和快速商业化提供了最佳解决方案。

DESCRIPTION (provided by applicant): The Biomarkers Reference Laboratory (BRL) at the Johns Hopkins Medical Institutions (JHMI) will serve as a Network resource for clinical and laboratory validation of biomarkers, which includes technological development, assay standardization, and method refinement. The JHMI clinical laboratory is Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified for the examination of human specimens for the diagnosis, prevention, or treatment of any disease. Based on our >20 years of experience in Clinical Chemistry, immunoassay, quality control, standardization, automation, proteomics, and cancer biomarkers, we have the unique ability to develop, optimize, scale-up, and automate diagnostic assays. If appropriate, we will consult or contract with the diagnostics industry in the development and scale up of reagent components. We have established an extensive network of academic and industrial collaborators. During the past 20 years, we have successfully conducted over 50 research projects funded by industry in the areas of cancer biomarkers and/or automated immunoassay systems including development, validation, and clinical studies leading to approval by the Food and Drug Administration (FDA). In addition, we are interested in performing a developmental study on the improvement of technologies for validation studies including bioinformatics, protein characterization, and multiplexing of biomarkers. The techniques that we propose include immunoassay, e.g. ELISA, protein chips e.g. SELDI technology, chromatography, e.g. HPLC and mass spectrometry for protein characterization. We propose forming a scientific advisory panel consisting of leaders from the industrial and academic communities to provide expert advice on specific issues pertaining to the development and validation of new cancer biomarkers. The advisory panel of experts includes clinical oncologists, urologists, cancer biologists, molecular and anatomic pathologists, and diagnostic industry scientists. We believe that this multidisciplinary approach offers the best solution for the identification, validation, and rapid commercialization of cancer biomarkers for clinical use.