Chagas Biomarkers Development Programme
Chagas disease, also known as American trypanosomiasis, is a potentially life-threatening disease caused by the parasite Trypanosoma cruzi. It is most commonly transmitted by biting insects known as ‘kissing bugs’ that are infected with the parasite. It can also be passed from mother to child during pregnancy and childbirth. As people typically show no symptoms for many years, most are unaware they have Chagas.
- Over 8 million people estimated to have Chagas in the world, with over 100 million people at risk
- 30,000-40,000 new cases per year
- Over 10,000 deaths per year
- Over 2 million women of childbearing potential living with Chagas
- Less than 10% of those infected have been diagnosed
- Endemic in 21 countries across Latin America and present in North America, Europe, Japan and Australia
Our collaboration with the DNDi & Novartis
For decades, a major challenge in drug development for Chagas disease has been the lack of analytical tools suitable for monitoring disease progression and response to treatment. There was no single reliable test of cure that can be used to monitor the efficacy of a treatment in adult chronic Chagas disease patients in a timely manner. The lack of validated early markers of parasitological cure has posed a significant hurdle for the development and regulatory approval of new drugs.
To solve this challenge, INFYNITY BIOMARKERS has partnered with
DNDi to develop a test able to detect a response to treatment more quickly than conventional techniques – potentially helping to accelerate development and facilitate registration of new treatments. Since 2024, InfYnity Biomarkers has also been collaborating with
Novartis using the Multicruzi assay to evaluate new drug candidates for the treatment of Chagas disease (A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease).
A unique expertise: the MultiCruzi Kit
The MultiCruzi test is a high-resolution multiplex ELISA assay for research use only (RUO), enabling the simultaneous detection and characterization of antibodies against 15 distinct T. cruzi antigen specificities.
Designed for both confirmatory testing and longitudinal monitoring, MultiCruzi provides a comprehensive antibody reactivity profile and enables the assessment of antibody level changes over time. Its optimized sample dilution strategy supports the quantification of antibody decline, offering a valuable tool for monitoring treatment response and following changes in antibody levels over time.
Advantages
- Comprehensive serological profiling: Generates an individual serological signature by simultaneously measuring antibody reactivity against 15 distinct T. cruzi antigens
- Extensively evaluated: tested on more than 4 000 serum samples across clinical studies and research cohorts
- Low sample volume: Requires only a small volume of serum/plasma (~5 µL) to generate a comprehensive serological profile
- Quantitative monitoring of antibody dynamics: Through multi-dilution analysis and the calculation of DF50, MultiCruzi enables quantitative assessment of changes in antibody reactivity over time
- Simplified data analysis: automated processing and standardized analysis of multiplex results, facilitating interpretation and reducing manual data handling
Related publications
Liste des services
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A Perspective on Biomarkers, Candidates for Surrogate End Points to Accelerate Successful Development of New Antiparasitic Agents for the Treatment of Chronic Chagas DiseaseWrite a description for this list item and include information that will interest site visitors. For example, you may want to describe a team member's experience, what makes a product special, or a unique service that you offer.
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A Serological Method's Ability to Distinguish Treatment Regimens by Assessing Early Antibody Decline in Chagas Patients: Insights From E1224 DataListe des éléments 3
A new study revealing that MultiCruzi enables the early assessment of treatment-associated biological responses in adults with Chagas disease, with antibody decline serving as an exploratory pharmacodynamic marker.
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2025 Project of the Year in pre-clinical research: Biomarkers for Chagas disease programmeListe des éléments 1
DNDi partnered with InfYnity Biomarkers to develop a test able to detect a response to treatment more quickly than conventional techniques – potentially helping to accelerate development and facilitate registration of new treatments. The InfYinity-developed assay called MultiCruzi can detect 15 different antibodies specific to the Trypanosoma cruzi parasite in patients’ blood.
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Early assessment of antibodies decline in Chagas patients following treatment using a serological multiplex immunoassayListe des éléments 2
In 2024, results from tests of the MultiCruzi assay were published in Nature Communications – for the first time demonstrating a decline in T. cruzi antibodies in patients treated for Chagas after 6 and 12 months of follow-up in adult Chagas patients in the BENDITA clinical trial. Analysis of the same samples, conducted at CONICET in Argentina for both the BENDITA and E1224 clinical trials, was completed, confirming the robustness and reproducibility of the MultiCruzi assay results.
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Comparing in vivo bioluminescence imaging and the Multi-Cruzi immunoassay platform to develop improved Chagas disease diagnostic procedures and biomarkers for monitoring parasitological cureWrite a description for this list item and include information that will interest site visitors. For example, you may want to describe a team member's experience, what makes a product special, or a unique service that you offer.
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Development of a Novel Multiplex Immunoassay Multi-cruzi for the Serological Confirmation of Chagas DiseaseWrite a description for this list item and include information that will interest site visitors. For example, you may want to describe a team member's experience, what makes a product special, or a unique service that you offer.
