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Scalable Urine Test for Microplastics and Nanoplastics: Development Progress, Regulatory Strategy, and Planned Observational Study
Summary
Researchers described progress toward a smartphone-compatible urine assay for microplastic and nanoplastic detection designed for repeated home use, outlining its regulatory strategy, prototype development stages, and a planned observational study to validate real-world exposure monitoring in human populations.
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.