Clinical and Analytical Validation of Cancer Biomarkers

描述（由申请人提供）：本提案是我们EDRN生物标志物参考实验室（BRL）的更新，该实验室位于约翰霍普金斯医疗机构约翰霍普金斯医学实验室（JHML）的临床化学部门（CCD）内。BRL将继续作为生物标志物临床和实验室验证的网络资源，包括技术开发和分析改进。JHML由美国病理学家学会（CAP）认证，并由CLIA（1988年临床实验室改进修正案）监管。因此，JHML遵循严格的良好实验室规范（GLP）指导方针进行质量控制和质量保证。拟议的开发项目将在约翰霍普金斯大学生物标志物发现中心（CBD）进行。该项目的目标是利用质谱、蛋白质/凝集素微阵列、生物信息学和免疫分析等尖端技术，验证糖蛋白作为侵袭性前列腺癌早期检测的生物标志物。我们组建了一支强大的研究和临床科学家团队，他们在癌症生物标志物和技术开发、研究设计、生物信息学、验证和翻译方面拥有多年的经验。PI陈博士同时担任CCD和CBD的主任。他在临床化学方面有30多年的经验，并进行了许多由行业资助的癌症诊断研究（bbb50），导致FDA批准临床使用。最近，第一个体外诊断多变量指数测定（IVDMIA）被FDA批准用于临床。这个测试，OVAl，是基于我们最初发表在《癌症研究》上的多重蛋白质组学研究。此外，来自诊断行业的几位顶尖科学家将担任顾问，提供专业知识，促进癌症诊断的开发和验证。在这次更新中，我们计划通过网络合作继续我们对EDRN使命的坚定承诺，并在生物标志物验证和技术/分析改进方面发挥领导作用。有了这个多学科的科学家团队，约翰霍普金斯大学的BRL为癌症生物标志物的成功验证和转化为癌症早期检测的临床提供了最好的机会。

DESCRIPTION (provided by applicant): This proposal is a renewal of our EDRN Biomarker Reference Laboratory (BRL) which is located within the Clinical Chemistry Division (CCD) of the Johns Hopkins Medical Laboratories (JHML) at the Johns Hopkins Medical Institutions. The BRL will continue to serve as a network resource for clinical and laboratory validation of biomarkers, which includes technological developments and assay refinement. The JHML are certified by the College of American Pathologist (CAP) and regulated by CLIA (Clinical Laboratory Improvement Amendments of 1988). As such, the JHML follow stringent, good laboratory practice (GLP) guidelines for quality control and quality assurance. The proposed developmental project will be conducted at the Center for Biomaricer Discovery (CBD), The Johns Hopkins University. The project goal is to validate glycoproteins as biomarkers for the early detection of aggressive prostate cancer using cutting edge technologies such as mass spectrometry, protein/lectin microarrays, bioinformatics, and immunoassays. We have assembled a strong team of research and clinical scientists based on many years of experience with cancer biomarkers and in technology development, study design, bioinformatics, validation, and translation. Dr. Chan, the PI, is the Director of both CCD and CBD. He has over 30 years of experience in clinical chemistry and has conducted many (> 50) research studies funded by industry on cancer diagnostics leading to the approval by the FDA for clinical use. Most recently, the first in vitro diagnostic multivariate index assay (IVDMIA) was cleared by the FDA for clinical use. This test, OVAl, was based on our original multiplex proteomic study published in Cancer Research. In addition, several leading scientists from the diagnostics industry will serve as consultants to provide expertise and facilitate the development and validation of cancer diagnostics. In this renewal, we plan to continue our strong commitment to the EDRN mission through network collaborations, and provide leadership in biomarker validation and technology/assay improvement. With this multi-disciplinary team of scientists, the BRL at Johns Hopkins offers the best opportunity for the success of cancer biomarker validation and translation into the clinic for the early detection of cancer.