FDA grants Breakthrough Device designation to Natera MCED assay
Natera said the U.S. FDA granted Breakthrough Device designation to its multi-cancer early detection (MCED) assay.
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12:00:54 PM UTC
SquawkNews
Natera received FDA Breakthrough Device designation for its multi-cancer early detection assay, based on data from 12 cancer types assessing sensitivity, specificity, and cancer signal origin.Material DetailsContext by AI AnalystThis is an early-to-mid step in Natera’s expansion into oncology scree…