Biomarker Reference Laboratory

我们建议的EDRN BRL，位于约翰霍普金斯大学临床化学部(CCD)内 医疗机构将成为BCC不可分割的一部分。BRL将继续作为以下网络资源 生物标志物的临床和实验室验证，包括技术开发和分析改进， 以及质量管理和法规要求方面的知识。我们的实验室通过了CAP认证 并受CLIA监管(提供证书)。我们严格遵循GLP的质量控制和质量指南 保证。北京交通大学拟议的产品开发项目将在JHU中心进行 生物标记物发现和翻译(CBDT)。该项目的目标是验证前列腺癌生物标记物。 由我们的BDL和BRL在当前资金期内发现，从BDL组件中重新发现 使用尖端技术从EDRN内外获得新的BCC和/或其他潜在的生物标记物 在蛋白质组学、生物信息学和临床化验发展方面。建议的诊断产品是体外试验。 由一组生物标志物组成的诊断多变量指数分析(IVDMIAs)有助于 术前评估PCA的侵袭性并决定加入主动监测(AS)；以及 2)用于检测AS期间进展风险上升的非侵入性生物标志物 为可能的疾病重新分类而进行的检查程序。我们组建了一支强大的研究团队和 具有多年癌症生物标志物和技术开发经验的临床科学家，研究 设计、生物信息学、验证和翻译。陈博士，联络PI和BRL PI，是 Ccd和cbdt。他在临床化学方面有30年的经验，并进行了许多(&gt；75) 由行业资助的癌症诊断研究导致FDA批准临床使用。此外， 来自诊断行业的几位顶尖科学家将担任合作者，提供专业知识和 促进产品开发和验证。我们的BRL非常有成效。自成立以来， EDRN自2000年以来，已有8种EDRN开发的分析方法被FDA批准用于临床，其中 第八，我们的BRL领导了卵巢癌OVA1和OVA血清IVDMIAs的开发，领导了血清 ProPSA验证研究，并作为尿PCA3验证试验的参考实验室。此外，陈博士 参与了米诺米奇国际有限公司开发的MiCheck前列腺癌测试。这项测试是 授权给CLIA认证的实验室。在这项申请中，我们计划继续我们对EDRN任务的承诺 通过与BCC、CVC和DMCC的网络协作。有了这个多学科的科学家团队 和临床医生，JHU的BRL为癌症生物标志物验证和成功提供了最好的机会 翻译。如果前列腺癌的过度治疗、治疗不足和不必要的活检减少可以 成功地解决与前列腺癌诊断和治疗相关的发病率可以是 显著降低，同时提高了对具有临床意义的前列腺癌的检测和治疗。

Our proposed EDRN BRL, which is located within the Clinical Chemistry Division (CCD) of the Johns Hopkins Medical Institutions, will be an integral part of the BCC. The BRL will continue to serve as a network resource for clinical and laboratory validation of biomarkers, which includes technological development and assay refinement, as well as knowledge of quality management and regulatory requirements. Our laboratory is certified by CAP and regulated by CLIA (certificates provided). We follow stringent GLP guidelines for quality control and quality assurance. The proposed product developmental project of the BCC will be conducted at the JHU Center for Biomarker Discovery and Translation (CBDT). The project goal is to validate prostate cancer biomarkers discovered by our BDL & BRL during the current funding period, de novo discoveries from the BDL component of the new BCC, and/or other potential biomarkers from within and outside EDRN using cutting edge technologies in proteomics, bioinformatics, and clinical assay development. The proposed diagnostic products are in vitro diagnostic multivariate index assays (IVDMIAs) consisting of a panel of biomarkers 1) to assist in the preoperative assessment of PCa aggressiveness and decision for enrollment into active surveillance (AS); and 2) non-invasive biomarkers for the detection of rising risk of progression during AS to triage patients for additional workup procedures for possible disease reclassification. We have assembled a strong team of research and clinical scientists with many years of experience with cancer biomarkers and in technology development, study design, bioinformatics, validation, and translation. Dr. Chan, the contact PI and the BRL PI, is the Director of both CCD and CBDT. He has >30 years of experience in clinical chemistry and has conducted many (>75) research studies funded by industry on cancer diagnostics leading to FDA approval for clinical use. Furthermore, several leading scientists from the diagnostics industry will serve as collaborators to provide expertise and facilitate product development and validation. Our BRL has been extremely productive. Since the inception of the EDRN in 2000, eight EDRN developed assays have been approved by the FDA for clinical use and of these eight, our BRL led the development of the OVA1 and Overa serum IVDMIAs for ovarian cancer, led the serum proPSA validation study, and served as the reference lab for the urine PCA3 validation trial. In addition, Dr. Chan was involved in the development of the MiCheck Prostate cancer test by Minomic International Ltd. This test was licensed to a CLIA certified lab. In this application, we plan to continue our commitment to the EDRN mission through network collaborations with BCCs, CVCs, and the DMCC. With this multi-disciplinary team of scientists and clinicians, the BRL at JHU offers the best opportunity for the success of cancer biomarker validation and translation. If the over-treatment, under-treatment and decrease in unnecessary biopsies in prostate cancer can be successfully addressed, the morbidities associated with prostate cancer diagnosis and treatment can be significantly decreased, while enhancing the detection and treatment of clinically significant prostate cancer.