Bionanao Genomics Inc (BNGO)

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OGM & FDA: The Saga Continues


The FDA’s shift toward AI-based computational models for drug testing could pave the way for optical genome mapping (OGM) to gain regulatory approval. The agency is phasing out animal testing in favor of human-relevant methods, including AI-driven toxicity models, organ-on-a-chip systems, and computational simulations.

While the FDA has not yet issued specific guidance on OGM, its focus on advanced genomic tools suggests that technologies like OGM could be fast-tracked for validation in clinical diagnostics and drug development.