# Biomarker Reference Lab

> **NIH NIH U2C** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2024 · $85,447

## Abstract

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.

## Key facts

- **NIH application ID:** 10837153
- **Project number:** 5U2CCA271890-02
- **Recipient organization:** NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- **Principal Investigator:** Leopoldo Nicolas Segal
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $85,447
- **Award type:** 5
- **Project period:** 2023-05-04 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10837153

## Citation

> US National Institutes of Health, RePORTER application 10837153, Biomarker Reference Lab (5U2CCA271890-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10837153. Licensed CC0.

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