# Biomarker-Based Test of Cure for Chagas Disease

> **NIH NIH R43** · KEPHERA DIAGNOSTICS, LLC · 2020 · $300,000

## Abstract

Project Summary
Chagas disease, caused by infection with the parasite Trypanosoma cruzi, is the most prevalent parasitic
disease in the western hemisphere, infecting 8-11 million individuals and with over 70 million at risk. The infection
is transmitted by an insect vector, but can also be acquired through blood transfusion, organ transplant, or
congenitally. Following a brief acute phase, the parasite persists for years as a chronic, but often asymptomatic
infection, which may progress to cardiomyopathy and other pathological conditions leading to severe morbidity
and mortality. In the U.S., the prevalence of T. cruzi infection in immigrant populations has led to the
implementation of blood screening assays to prevent transfusion transmission. Autochthonous transmission can
be expected based on the gradual encroachment of the insect vector into the southernmost regions of the U.S.
Treatment for Chagas disease currently relies on two drugs, benznidazole and nifurtimox. While these drugs are
highly effective if used during the acute phase, their efficacy in the chronic phase varies significantly, decreasing
with increasing duration of infection. Moreover, due to their known toxicity, both drugs are known to have frequent
adverse effects, which intensify with patient age. Benznidazole has been approved by FDA only for use on
children aged 2-12, while nifurtimox is not FDA-approved; both drugs can only be obtained in the U.S. from CDC
for use outside the approved indication. Accordingly, a variety of efforts are underway to develop new drugs to
treat Chagas disease, supported by public health organizations and pharmaceutical companies. However, a
major limitation is the lack of a reliable, standardized and validated test of cure to measure the efficacy of Chagas
drugs and to establish whether treatment has successfully eradicated an individual patient’s infection for
purposes of clinical management.
The aim of this project is the development of a test of cure for Chagas disease that will address these needs. Of
the methodologies that have been evaluated for measuring drug effects on T. cruzi infection, serology and PCR
have been the mainstays. A decrease in antibody titer to one or another T. cruzi antigen over a period of time
following treatment has been used in various studies as a de factor test of cure, but the in-house assays used
have not been standardized or validated and are not commercially available. PCR offers high positive predictive
value, but its low negative predictive value excludes it as a methodology for a bona fide test of cure. Approach
to assay development will be on the measurement of antibody response to a set of T. cruzi peptide antigens
selected based on immunological characteristics. Assays will be developed first in ELISA and subsequently in
point-of-care formats to address the needs of drug trials and individual patient management. Performance of the
test-of-cure assays will be evaluated on available sets of well-charact...

## Key facts

- **NIH application ID:** 9978716
- **Project number:** 5R43AI147973-02
- **Recipient organization:** KEPHERA DIAGNOSTICS, LLC
- **Principal Investigator:** Andrew E. Levin
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $300,000
- **Award type:** 5
- **Project period:** 2019-07-16 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9978716

## Citation

> US National Institutes of Health, RePORTER application 9978716, Biomarker-Based Test of Cure for Chagas Disease (5R43AI147973-02). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/9978716. Licensed CC0.

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