# Lung Cancer, DNA Methylation, and Liquid Biopsy

> **NIH NIH R43** · PRECISION EPIGENOMICS, INC. · 2022 · $397,831

## Abstract

ABSTRACT
Non-small cell lung cancer (NSCLC) remains a devastating disease with overall poor prognosis. Major
contributing factors include obstacles to diagnosing the disease early in its course and limitations in
currently available approaches to monitor therapeutic response. A liquid biopsy, or blood sample, can
provide the epigenetic landscape of all cancerous lesions (primary and metastases). In addition, it offers
the opportunity to systematically monitor cancer disease as the quantification of circulating cell-free
DNA (cfDNA) has been shown to correlate with tumor burden. The practice of liquid biopsy as a
diagnostic and prognostic tool in lung cancer patients is gradually becoming an appealing approach in
the clinical routine practice, since it is noninvasive and can be easily repeated. We previously reported
in silico identification of novel DNA methylation loci specifically hypermethylated in common human
cancers that could be used as epigenetic biomarkers. Using a unique DNA methylation specific qPCR
approach, we clinically tested a group of these cancer-specific loci on cell-free DNA (cfDNA) extracted
from the plasma fraction of blood samples from healthy controls and NSCLC patients. These DNA
methylation biomarkers distinguish lung cancer cases from controls with high sensitivity and specificity
(AUC = 0.96). In well-defined patient cohorts, we will assess the performance of our DDX-Sentinel
biomarkers to: 1) Identify cancer in indeterminate pulmonary nodules and identified by CT screening
of high-risk individuals and 2) Evaluate the capability of DDX-Sentinel Biomarkers to monitor response
to surgical resection. These studies will position us for a future Phase II submission.

## Key facts

- **NIH application ID:** 10257798
- **Project number:** 1R43CA257133-01A1
- **Recipient organization:** PRECISION EPIGENOMICS, INC.
- **Principal Investigator:** Mark Anthony Nelson
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $397,831
- **Award type:** 1
- **Project period:** 2022-03-01 → 2024-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10257798

## Citation

> US National Institutes of Health, RePORTER application 10257798, Lung Cancer, DNA Methylation, and Liquid Biopsy (1R43CA257133-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10257798. Licensed CC0.

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