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Diagnosis of Esophageal Squamous Cell Carcinoma in Low-Income Countries

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA261376-01A1
Agency Tracking Number: R41CA261376
Amount: $399,995.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PAR18-802
Solicitation Year: 2018
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-21
Award End Date (Contract End Date): 2022-09-27
Small Business Information
1104 ELM RD
Halethorpe, MD 21227-3936
United States
DUNS: 116914502
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (443) 942-2127
Business Contact
Phone: (443) 942-2127
Research Institution
SAN FRANCISCO, CA 94143-2510
United States

 Nonprofit College or University

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.Esophageal Squamous Cell Cancer (ESCC) is a serious world-wide health problem with low
survival levels. This STTR Phase I application details the development of a novel diagnostic
assay to detect ESCC in low- to middle income countries, where the incidence and death
rate from ESCC are considerably higher than in other nations.

* Information listed above is at the time of submission. *

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