Volume 4, 2025

Lateral flow assay-based detection of nuclear fusion oncoprotein: implications for screening of acute promyelocytic leukemia

Abstract

Due to the slow progression of most cancers, speed of diagnosis is not of primary concern. However, the diagnosis of acute promyelocytic leukemia (APL) is unusually urgent because its hemorrhagic complications can result in death within a few days. APL is highly treatable, but the turnaround time for standard molecular testing often exceeds the window for life-saving treatment, even in advanced medical centers. The hallmark of APL is the fusion of the PML and RARα genes (t(15;17)) resulting in the expression of a growth-promoting PML–RARα fusion protein. Toward timely screening for APL, we have developed a sensitive europium-based lateral flow immunoassay for direct detection of nuclear PML–RARα fusion oncoprotein. We demonstrated a limit of detection of 11% fusion protein positive NB4 cells spiked into healthy peripheral blood mononuclear cells and an integrated filter-based sample preparation workflow showcasing its potential for clinically actionable utility in prompt APL screening. With further validation with clinical human samples this lateral flow immunoassay has the potential to enable fusion-protein based cancer diagnostics at true point-of-care.

Graphical abstract: Lateral flow assay-based detection of nuclear fusion oncoprotein: implications for screening of acute promyelocytic leukemia

Supplementary files

Article information

Article type
Paper
Submitted
04 Dec 2024
Accepted
12 Mar 2025
First published
21 Mar 2025
This article is Open Access
Creative Commons BY-NC license

Sens. Diagn., 2025,4, 416-424

Lateral flow assay-based detection of nuclear fusion oncoprotein: implications for screening of acute promyelocytic leukemia

M. Chabi, B. Vu, K. Brosamer, S. Song, V. Maranholkar, Z. Zeng, Y. Zu, R. Kanagal-Shamanna, J. C. Conrad, R. C. Willson and K. Kourentzi, Sens. Diagn., 2025, 4, 416 DOI: 10.1039/D4SD00357H

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