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Scalable Urine Test for Microplastics and Nanoplastics: Development Progress, Regulatory Strategy, and Planned Observational Study
Summary
Researchers are developing a smartphone-based urine assay for routine microplastic and nanoplastic exposure monitoring, with FDA Pre-Submission engagement underway and an observational study planned for late 2026, aiming to make home-based longitudinal exposure measurement practical and scalable.
Microplastics and nanoplastics (MPs/NPs) have been increasingly reported in human biological systems, yet scalable routine monitoring tools remain limited. Current approaches rely largely on specialized laboratory workflows that are expensive, slow, contamination-sensitive, and not designed for repeat home use. This paper outlines progress toward a smartphone-based urine assay intended for environmental exposure awareness and longitudinal wellness monitoring. The program includes prototype development, regulatory planning through FDA Pre-Submission engagement (Q-Sub submitted), and a planned observational study beginning in late summer or fall 2026. The broader goal is to make routine exposure measurement more accessible, practical, and scalable.