# Validation and Early Commercialization of the ENVISAGE Assay, a Prognostic Test for Barrett's Esophagus

> **NIH NIH R44** · CAPSULOMICS, LLC · 2024 · $832,997

## Abstract

Barrett’s esophagus (BE) is the strongest known risk factor for, and obligate precursor of, esophageal high-
grade dysplasia (HGD) and adenocarcinoma (EAC). However, determining future neoplastic progression risk
is quite challenging in BE patients: current risk estimation is based solely on highly variable, subjective,
observer-dependent histopathologic diagnoses (i.e., non-dysplastic (ND), Low-Grade Dysplasia (LGD),
Indeterminate for Dysplasia (IFD), or High-Grade Dysplasia (HGD). Our ENVISAGE assay is a validated
(CLIA # 21D2256153) laboratory-developed test (LDT) based on a 4-gene-plus-patient age DNA
methylation-based PCR assay that was developed at Capsulomics built on foundational studies performed
at Johns Hopkins University (JHU). Our preliminary studies yielded a ready-to-launch 1st-generation assay
that accurately predicts the risk of future neoplastic progression in BE patients based on levels of molecular
biomarkers. This prognostic assay risk-stratifies patients to vastly improve clinical decision-making, with a
sensitivity of 71% and a specificity of 90%, outperforming any other clinically available tests.
Notwithstanding this early success, we have identified a need for further improvement as well as a robust
commercialization pathway. With funding of this direct-to-phase II proposal, we will make significant
improvements to generate a more sensitive, more robustly validated second-generation product, while
building a foundation for strategic commercialization and market adoption of both the current and future
assays. Aim 1 will address assay sensitivity challenges due to using limited-quantity, low-quality fragmented
DNA from biopsy specimens by engineering a new assay based on multiplex PCR. This advancement will
also improve throughput, efficiency, cost, and processing speed. Aims 2 and 3 will augment our study
population while incorporating the new multiplex protocol from Aim 1, retain and refine our algorithm to
produce a 2nd-generation ENVISAGE assay, and more sharply delineate which patients will fall into the
“Intermediate” risk category for improved clinical management. Aim 4 will establish early commercialization
of the 1st-generation assay as an LDT while developing a platform for the future launch of our 2nd-generation
product. Thus, this direct-to-phase II SBIR proposal will expand, refine, and validate the ENVISAGE assay,
a novel LDT for stratifying future neoplastic progression risk in BE patients, thereby improving clinical
decision-making.

## Key facts

- **NIH application ID:** 10923931
- **Project number:** 5R44DK136424-02
- **Recipient organization:** CAPSULOMICS, LLC
- **Principal Investigator:** Sarah Laun
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $832,997
- **Award type:** 5
- **Project period:** 2023-09-15 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10923931

## Citation

> US National Institutes of Health, RePORTER application 10923931, Validation and Early Commercialization of the ENVISAGE Assay, a Prognostic Test for Barrett's Esophagus (5R44DK136424-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10923931. Licensed CC0.

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