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） 医疗机构，将是BCC的一个组成部分。BRL将继续作为网络资源， 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的知识。我们的实验室通过CAP认证 由CLIA监管（提供证书）。我们遵循严格的GLP质量控制和质量指导方针 保证。BCC的拟议产品开发项目将在JHU中心进行， 生物标志物发现和翻译（CBDT）。该项目的目标是验证前列腺癌的生物标志物 BDL和BRL在当前资助期内发现的新发现， 新的BCC和/或来自EDRN内外的其他潜在生物标志物， 蛋白质组学、生物信息学和临床检测开发。申报的诊断产品为体外产品 诊断多变量指数测定（IVDMIA），由一组生物标志物组成，1）以帮助 术前评估PCa侵袭性并决定是否纳入主动监测（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， 可能的疾病重新分类的检查程序。我们组建了一支强大的研究团队， 具有多年癌症生物标志物和技术开发经验的临床科学家， 设计、生物信息学、验证和翻译。陈博士，联系PI和BRL PI，是 CCD和CBDT。他在临床化学方面有超过30年的经验，并进行了许多（>75） 由行业资助的癌症诊断研究，导致FDA批准临床使用。此外，委员会认为， 来自诊断行业的几位顶尖科学家将作为合作者，提供专业知识， 促进产品开发和验证。我们的BRL非常富有成效。成立以来 在2000年的EDRN中，八种EDRN开发的测定方法已经被FDA批准用于临床使用，并且其中 八、我们的BRL主导开发了针对卵巢癌的OVA 1和Overa血清IVDMIAs，主导了血清 proPSA验证研究，并作为尿液PCA 3验证试验的参考实验室。此外，陈医生 参与了Minomic International Ltd.的MiCheck前列腺癌检测的开发。 授权给CLIA认证的实验室在这一应用中，我们计划继续我们对EDRN使命的承诺 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 JHU的BRL为癌症生物标志物验证的成功提供了最佳机会， 翻译.如果过度治疗、治疗不足和减少不必要的前列腺癌活检， 成功地解决，与前列腺癌诊断和治疗相关的发病率可以 显著降低，同时增强临床显著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.