Biomarker Reference Lab

项目总结（BRL）

Project summary (BRL) The ultimate goal of the NYU BCC EDRN is to develop Clinical Laboratory Improvement Amendments (CLIA) grade assays that will allow for identification of early stage lung cancer and will predict the risk of recurrence post-surgical removal of early stage disease. We already have promising data that this can be accomplished through evaluation of microbial and host genomic signatures. These will be further investigated in the Biomarker Developmental Laboratory (BDL) with agnostic omics approaches leading to identification of best performing predictive features. The goal of the Biomarker Reference Laboratory (BRL) is to develop standardized, analytically validated-biomarker assays that will target promising microbial and host signatures identified by the BDL. In order to do so, we will have matching plasmas, buffy coats, and lower airway samples to the ones used in the BDL for discovery as reference samples for “first order” clinical validation of our custom panels in the BRL. In Aim 1, we will develop a targeted microbial genomic next generation sequencing (NGS) panel for blood and lower airway samples predictive of diagnosis and prognosis of early-stage NSCLC. DNA probes will be designed targeting taxa identified in the BDL. In Aim 2, we will evaluate whether a targeted metabolite panel using an LC- MS approach in blood and lower airway samples can predict diagnosis and prognosis of early-stage NSCLC. In Aim 3, we will test a custom-made NanoString panel for RNA from buffy coats and lower airways targeting best performing features identified in the BDL. The cohort selected will be divided in Discovery and Validation. Successful biomarkers will then undergo external validation. The proposed work will be performed in our CLIA approved laboratory infrastructure. The pipelines developed here will provide a novel approach that can be customized to multiple targets identified by others in the EDRN consortium. While each approach is distinctly looking at microbial DNA, metabolites or host RNA target signatures, the consistent use of samples from a defined group of subjects will allow us to estimate the role of combining different types of biomarkers measured in parallel through different approaches for diagnostic and prognostic prediction. These investigations can then lead to the development of a new multi-approach biomarker that will identify high risk subjects where more aggressive interventions might be warranted.