GeneDx announced on 2025‑10‑22 that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its ExomeDx™ and GenomeDx™ tests, which are used to diagnose life‑threatening diseases or genetic disorders in symptomatic patients.
The Breakthrough Device Designation is reserved for technologies that can provide more effective diagnosis or treatment for life‑threatening or irreversibly debilitating diseases. It gives GeneDx an expedited review pathway, prioritized feedback, and closer collaboration with the FDA, accelerating the time to market for these diagnostic tests.
GeneDx has performed more than 2.5 million genetic tests and operates a CLIA‑certified, CAP‑accredited laboratory. Its tests are powered by GeneDx Infinity, the largest rare‑disease dataset, which underpins the high diagnostic yield and clinical utility of the ExomeDx™ and GenomeDx™ platforms.
The designation is a significant regulatory win that could speed FDA clearance, broaden reimbursement opportunities, and strengthen GeneDx’s competitive position in the rare‑disease diagnostics market.
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