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A Novel Strategy for Diagnosis of Esophageal Adenocarcinoma.

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA250779-01
Agency Tracking Number: R41CA250779
Amount: $320,428.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA18-591
Solicitation Year: 2018
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-06-19
Award End Date (Contract End Date): 2021-05-31
Small Business Information
1104 ELM RD
Halethorpe, MD 21227-3936
United States
DUNS: 116914502
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (410) 502-6059
Business Contact
Phone: (443) 942-2127
Research Institution
BALTIMORE, MD 21218-2680
United States

 Nonprofit College or University

Contact PD/PI: Abraham, John M
Esophageal adenocarcinoma (EAC) is one of two major types of esophageal cancer, which causes 509,000
deaths worldwide annually. EAC diagnosis is made using the invasive, expensive, risky, and not universally
accessible procedure, esophagogastroduodenoscopy (EGD). Thus, there is a pressing need for easier, safer,
cheaper strategies for EAC diagnosis. Our novel strategy builds on exciting preliminary data in EAC patients
involves a swallowable, retrievable sponge capsule device combined with a DNA methylation biomarker panel
(JHU patent pending). Capsulomics, a new startup established specifically for this project, will commercialize
this diagnostic assay, termed “EsoSAVE,” for EAC detection.This Phase I STTR application contains three Specific Aims to implement this strategy. Aim 1 will optimize
and validate the EsophaCap DNA extraction procedure. Aim 2 will generate a multi-parameter statistical model
to further strengthen our promising methylation biomarkers. Aim 3 will validate the EsoSAVE test in sponge
samples from normal and EAC patients. These Aims will address important scientific questions while
simultaneously advancing the EsoSAVE diagnostic test toward commercial implementation.
Project Summary/Abstract Page 6Contact PD/PI: Abraham, John M
This Phase I STTR application details the development of a novel diagnostic assay to detect
EAC based on a swallowable, retrievable sponge device combined with a promising DNA
methylation biomarker panel.
Project Narrative Page 7

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

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