# Diagnosis of Esophageal Squamous Cell Carcinoma in Low-Income Countries

> **NIH NIH R41** · CAPSULOMICS, LLC · 2021 · $399,995

## Abstract

Esophageal squamous cell carcinoma (ESCC) causes more than 509,000 deaths per year worldwide, and
over 80% of these cases occur in low- and middle-income countries (LMICs). In the settings where it is
available and affordable, ESCC diagnosis is made using the highly invasive and expensive procedure known
as esophagogastroduodenoscopy (EGD, also referred to as upper endoscopy). However, citizens of
underdeveloped countries often do not have widespread access to EGD; thus, there is a pressing need for
easier, safer, cheaper, more accessible ESCC diagnostic strategies. We have developed a strategy based on
our exciting preliminary data in ESCC patients: a swallowable, retrievable sponge-capsule device (EsophaCap)
combined with a sensitive, specific DNA methylation biomarker panel (JHU patent pending) and machine
learning classifiers. Capsulomics, Inc., a startup company from Johns Hopkins University, will commercialize
this assay, termed “EsoCAN,” for ESCC diagnosis.
 The goal of this project is to explore the feasibility and development of a non-endoscopic diagnostic test as
a more convenient, inexpensive, and more widely usable alternative to EGD in LMICs. Ultimately, this test,
when applied to at-risk populations, is likely to significantly improve survival and quality of life. As an initial
step toward this goal, we will pursue the following Specific Aims: Aim 1, analytical and clinical validation of
quantitative methylation-specific PCR (qMSP) assays for 5 candidate loci: cg20655070, SLC35F1, TAC1,
ZNF132, and ZNF542, including a pilot study of EsophaCap collected specimens from 50 ESCC patients and
70 controls, and Aim 2, creation of multivariate machine learning (ML) diagnostic biomarker models. In Phase
II, we will further develop and evaluate our non-endoscopic diagnostic test in a larger patient cohort for
accuracy of ESCC diagnosis in LMICs.

## Key facts

- **NIH application ID:** 10325590
- **Project number:** 1R41CA261376-01A1
- **Recipient organization:** CAPSULOMICS, LLC
- **Principal Investigator:** Daniel Gregory Lunz
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $399,995
- **Award type:** 1
- **Project period:** 2021-09-21 → 2023-09-27

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325590

## Citation

> US National Institutes of Health, RePORTER application 10325590, Diagnosis of Esophageal Squamous Cell Carcinoma in Low-Income Countries (1R41CA261376-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10325590. Licensed CC0.

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