by Loy T, Pinazo M-J, Alonso-Padilla J, Altcheh J, Braud-Pérez S, Scandale I, Gómez-Burgaz M, Saade U, Barreira F, Hochberg NS, Angyalosi G, Zrein M, Chatelain E. ACS Infection Diseases 2026. doi:10.1021/acsinfecdis.5c01096
Summary: Assessing efficacy of treatment in adults with chronic Chagas disease is challenging given the absence of validated biomarkers or surrogate end points. Biomarker development is complicated by the years to decades often required for conventional serology assays to detect treatment-associated changes, intermittent parasitemia, persistent antibody responses, the lack of direct measures of tissue parasite clearance, and limited longitudinal biorepositories for validation. The authors of this manuscript critically evaluate biomarkers, molecular approaches, and multiplex serological platforms such as MultiCruzi. Their potential utility, supporting evidence, methodological limitations, reproducibility, and validation status are assessed within a fit-for-purpose scientific and regulatory framework. The authors also address the evidentiary and regulatory challenges associated with biomarker qualification and propose a roadmap for future qualification efforts.
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