National Cancer Institute 5U2CCA271895-04

Biomarker Reference Laboratory

Award to Johns Hopkins University for the Biomarker Reference Laboratory project to validate prostate cancer biomarkers using advanced technologies, aiming to improve diagnostics and patient outcomes.

Description

Our proposed EDRN BRL, located within the Clinical Chemistry Division (CCD) of Johns Hopkins Medical Institutions, will serve as a network resource for clinical and laboratory validation of biomarkers, including technological development, assay refinement, quality management, and regulatory compliance. The project aims to validate prostate cancer biomarkers discovered by our BDL & BRL, de novo discoveries from the BDL component of the new BCC, and other potential biomarkers using cutting-edge technologies in proteomics, bioinformatics, and clinical assay development. The diagnostic products are in vitro diagnostic multivariate index assays (IVDMIAs) comprising panels of biomarkers to assist in preoperative assessment of prostate cancer (PCa) aggressiveness, decision-making for active surveillance (AS), and non-invasive detection of progression risk during AS for patient triage. Our team includes experienced research and clinical scientists, led by Dr. Daniel Wanyui Chan, Director of CCD and CBDT, with over 30 years in clinical chemistry and extensive experience in cancer diagnostics leading to FDA approvals. The BRL has a history of successful assay development, including FDA-approved tests for ovarian and prostate cancers. The project will continue collaborations with industry leaders and aims to address over-treatment and under-treatment issues in prostate cancer, reducing associated morbidities and improving detection and treatment of clinically significant prostate cancer.

View original record