AI Medicine Is Forcing The FDA To Rewrite The Rules | #194

2 Aug 2026 · 12 min
11:54

In this episode of the Dr. Joy Kong podcast, Dayan, co‑founder of Luventix and founder of Panaton, explains how his company is developing AI‑powered metabolomics diagnostics that analyze raw urine gas‑chromatogram data (≈38,250 data points per sample) from hundreds of patients without first identifying individual biomarkers. The AI model learns patterns across the entire metabolite spectrum to detect over 50 diseases, offering a holistic, system‑level view akin to Eastern medicine. Dayan describes how the technology can be used to select optimal cohorts and predict treatment response in clinical trials, functioning as a companion diagnostic. He outlines the regulatory strategy: initially pursuing a lab‑developed test (LDT) pathway before seeking FDA pre‑market approval, and discusses the FDA’s evolving stance on AI‑driven diagnostics, including challenges of continuous model updates. The conversation also covers the synergy between metabolomics and genomics, positioning metabolomics as a real‑time snapshot of organism state versus the static genetic blueprint. Finally, Dayan shares the commercialization roadmap—future test panels (GI, kidney, neurological) and the current unavailability of the product—while providing the company website (levantix.com) for future updates.

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