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Natera's Multi-Cancer Early Detection Assay Granted FDA Breakthrough Device Designation

Natera's Multi-Cancer Early Detection Assay Granted FDA Breakthrough Device Designation

MT newswireMT newswire2026/10/09 12:24

08:24 AM EDT, 10/09/2026 (MT Newswires) -- Natera's (NTRA) multi-cancer early detection assay has been granted Breakthrough Device Designation by the US Food and Drug Administration, the genetic testing company said Friday. The multi-cancer early detection assay works by analyzing cell-free DNA in the blood to screen for multiple cancers, according to a statement. The designation is intended to speed up development, assessment, review, as well as marketing authorization of medical devices, Natera said.

08:24 AM EDT, 10/09/2026 (MT Newswires) -- Natera's (NTRA) multi-cancer early detection assay has been granted Breakthrough Device Designation by the US Food and Drug Administration, the genetic testing company said Friday. The multi-cancer early detection assay works by analyzing cell-free DNA in the blood to screen for multiple cancers, according to a statement. The designation is intended to speed up development, assessment, review, as well as marketing authorization of medical devices, Natera said.
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