# MethylScan for Early Detection of Liver and Lung Cancer

> **NIH NIH R44** · EARLYDIAGNOSTICS, INC. · 2023 · $997,285

## Abstract

PROJECT SUMMARY
The long-term goal of this SBIR Phase II project is to develop and market a commercially viable, blood-based
methylation profiling test that can detect and locate multiple types of cancer early. Clinical intervention in the
early stages of cancer can greatly improve the survival of cancer patients. Despite the tremendous demand for
early detection methods in clinical practice, few commercial tests exist in the market. To address this unmet
need, in Phase I, we developed and validated a cell-free DNA Reduced Representation Bisulfite Sequencing
assay, MethylScan assay, to interrogate the methylation profile of cfDNA. The MethylScan assay was highly
reproducible and reliable at low input quantities of DNA and achieved high sensitivity and specificity for detecting
liver cancer. DNA methylation is established during early mammalian cell differentiation and plays an important
role in the development and progression of cancer; thus, it is an ideal biomarker not only for pan-cancer detection
but also for identification of tumor tissue of origin. The proposed project will translate the MethylScan assay to a
surveillance product for liver cancer and expand its intended use for early lung cancer detection in patients with
indeterminate lung nodules.
In this Phase II study, our specific aims are as follows: Aim 1) Optimize MethylScan assay and the workflow of
MethylScan Test; Aim 2) Perform a clinical validation to evaluate MethylScan test for early detection of HCC;
Aim 3) Perform a clinical validation to evaluate MethylScan test for early detection of lung cancer in patients with
indeterminate lung nodules. The MethylScan test will be used to perform cancer prediction in a cohort of 200
early HCC patients, 70 early lung cancer patients with malignant lung nodules, 200 patients at high risk for HCC
or 50 patients with benign lung nodules. Participants in the clinical validation study will be recruited from Midwest
and West Coast sites. The outcome of this project will support large clinical trials for MethylScan test as a
surveillance approach for patients at risk of liver and lung cancer. The data collected will be discussed with FDA
in a pre-submission meeting.

## Key facts

- **NIH application ID:** 10705298
- **Project number:** 5R44CA246941-03
- **Recipient organization:** EARLYDIAGNOSTICS, INC.
- **Principal Investigator:** Steven-Huy B Han
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $997,285
- **Award type:** 5
- **Project period:** 2020-06-01 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10705298

## Citation

> US National Institutes of Health, RePORTER application 10705298, MethylScan for Early Detection of Liver and Lung Cancer (5R44CA246941-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10705298. Licensed CC0.

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