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-treatme...