Biomarker Reference Lab

BIOMARKER REFERENCE LAB ABSTRACT The Biomarker Reference Laboratory (BRL) of the BU-UCLA Lung Cancer Biomarker Characterization Center (BCC) will work to ensure that the biomarkers developed and evaluated by our Biomarker Discovery Lab (BDL) can be robustly measured in the clinical setting using material collected and analyzed using CLIA-lab protocols. Like the BDL, the BRL will be organized into analyte specific teams. Reference Lab studies will be performed in collaboration with our industrial partners for the nasal gene expression, circulating tumor cell (CTC) and peripheral blood mononuclear cells (PBMC) biomarkers, and at the UCLA Imaging Biomarker Reference Laboratory (IBRL) for the imaging biomarkers. Each entity within the BRL has had a long-standing collaboration with our BDL teams. The BRL will also assess biospecimen, imaging and molecular data quality and convey that information to the collecting sites and the BDL to ensure that all sites are collecting high quality specimens and generating high quality data. The goals of these collaborative efforts are to rigorously assess the validity of candidate biomarkers for the early detection of lung cancer that are identified in the BDL, and develop either refined algorithms that currently exist in our commercial partners’ laboratories or novel CLIA assays that can emerge in the commercial marketplace for clinical use. The major goals are that these tests have high reproducibility, accuracy, precision, sensitivity, and specificity.