# Biomarker-Based Test of Cure for Chagas Disease

> **NIH NIH R44** · KEPHERA DIAGNOSTICS, LLC · 2024 · $1,013,849

## Abstract

Project Summary
Chagas disease, caused by infection with 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, 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 has been approved for children up to age 18; adults are currently treated off-label. 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 to measure the efficacy of Chagas drugs and to establish whether treatment is successfully
eliminating an individual patient’s infection for purposes of clinical management.
The aim of this project is the development of a test that measures the response to treatment in Chagas disease
patients that will address these needs. Of the methodologies that have been evaluated for measuring effects of
drug treatment on T. cruzi infection, serology has been the mainstay. A decrease in antibody titer to T. cruzi
over time following treatment has been used as a de facto test for treatment response, but no commercial assay
has been designed and validated for this use, and available assays only show changes in antibody titer over a
period of many years. In Phase I, we identified T. cruzi peptide antigens to which IgG antibody titers declined
rapidly in treated patients, providing a sensitive means to measure treatment response within a year. Prototype
assays based on these peptides have been developed in both ELISA and lateral flow formats to enable testing
in both laboratory and point-of-care settings. In Phase II, the performance of the assays as indicators of treatment
response will be evaluated in comparison with conventional serological tests and PCR on well-characterized
retrospective serum samples obtained a...

## Key facts

- **NIH application ID:** 10920488
- **Project number:** 5R44AI147973-04
- **Recipient organization:** KEPHERA DIAGNOSTICS, LLC
- **Principal Investigator:** Andrew E. Levin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,013,849
- **Award type:** 5
- **Project period:** 2019-07-16 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10920488

## Citation

> US National Institutes of Health, RePORTER application 10920488, Biomarker-Based Test of Cure for Chagas Disease (5R44AI147973-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10920488. Licensed CC0.

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