# Core D: Biomarkers, Genomics & Epigenomics Core

> **NIH NIH U54** · ROSWELL PARK CANCER INSTITUTE CORP · 2022 · $627,534

## Abstract

BGE CORE SUMMARY: The goal of the Biomarkers, Genomics and Epigenomics (BGE) Core is to facilitate
and co-ordinate biospecimen analysis across Projects 1-3 within the WNY Center for Research on Flavored
Tobacco Products (CRoFT) to strengthen the overall themes and enhance scientific productivity. The main
focus of the BGE core is to provide centralized workflow standards for in vitro and in vivo exposure from
electronic nicotine delivery systems (ENDS)/cigarillos/waterpipe tobacco and to determine biomarkers of
exposure and potential harm in biofluids, primary cells and tissues. These synchronized efforts will increase
efficacy and ensure valid, high precision protocols and reproducible methods around flavored tobacco products
suitable for the regulatory needs of the FDA-CTP. We have provided evidence that shows altered systemic
biomarkers, genomic and epigenomic signatures in air vs. tobacco/cigarette smoke (CS) exposed mouse and
human non-smokers vs. smokers confirmed by luminex, ELISA, mass spectrometry, genomics and
epigenomics approaches. We are aware that flavored tobacco products can affect systemic biomarkers of
potential harm including genomic and epigenomic signatures that will be investigated under specific aims 1-3:
Aim 1: Standardize experimental conditions, focusing on laboratory testing, biochemical assays and
analytical methods to measure biomarkers of potential harm from exposure to flavored tobacco
products. We will obtain biospecimens/samples from Projects (1-3) to analyze for biomarkers of exposure and
potential harm (toxicity) including standard biochemical assays. In addition, BGE core will support the human
studies to verify the nicotine intake, exposure status of tobacco products in plasma, saliva and urine samples.
Aim 2: Develop standard bioassays to identify existing/known and newer circulating biomarkers in
biological fluids, primary cells and pre-clinical mouse models using genomic and epigenomic
approaches. We will assess existing biomarkers as well as develop methods for identification of novel
biomarkers (extracellular vesicle/exosomes) of exposure/potential harm using cutting-edge genomics and
epigenomics approaches to guide regulation of flavored tobacco products.
Aim 3: Develop a multivariate toxicity ranking system based on the assessment of toxicity/biological
effects/health outcomes measured from flavored tobacco products. We will develop a multivariate toxicity
ranking systems based on biomarkers of potential harm, genomic and epigenomic signatures assessed by the
BGE core along with the involvement of BI (Biostatistics and Informatics) core for in-depth biostatistical
analysis. The overall goal of BGE core is to provide novel technologies needed for testing biomarkers in the
biofluids, primary cells and pre-clinical models. BGE core will provide a central resource for development and
performance of assays as per good laboratory practice (GLP) standards relevant for informing the FDA’s
regulation of the manu...

## Key facts

- **NIH application ID:** 10475786
- **Project number:** 5U54CA228110-05
- **Recipient organization:** ROSWELL PARK CANCER INSTITUTE CORP
- **Principal Investigator:** Isaac Kirubakaran Sundar
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $627,534
- **Award type:** 5
- **Project period:** 2018-09-14 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10475786

## Citation

> US National Institutes of Health, RePORTER application 10475786, Core D: Biomarkers, Genomics & Epigenomics Core (5U54CA228110-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10475786. Licensed CC0.

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