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）的生物标志物参考实验室（BRL）将作为生物标志物临床和实验室验证的网络资源，包括技术开发、测定标准化和方法改进。JHMI临床实验室是1988年临床实验室改进修正案（CLIA）认证的，可用于诊断、预防或治疗任何疾病的人体标本检查。基于我们在临床化学、免疫测定、质量控制、标准化、自动化、蛋白质组学和癌症生物标志物领域超过20年的经验，我们拥有开发、优化、扩大规模和自动化诊断分析的独特能力。在适当的情况下，我们将与诊断行业协商或签订合同，开发和扩大试剂组分。我们建立了广泛的学术和工业合作者网络。在过去的20年里，我们成功地进行了50多个由行业资助的癌症生物标志物和/或自动免疫测定系统领域的研究项目，包括开发、验证和临床研究，并获得了美国食品药品监督管理局（FDA）的批准。此外，我们有兴趣对验证研究的技术改进进行开发研究，包括生物信息学，蛋白质表征和生物标志物的多重化。我们提出的技术包括免疫测定，例如ELISA，蛋白芯片，例如SELDI技术，色谱法，例如HPLC和质谱法用于蛋白质表征。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，就与开发和验证新的癌症生物标志物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的科学家。我们相信，这种多学科方法为临床使用的癌症生物标志物的鉴定、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.