The Cancer Letter

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Drugs & Targets

FDA grants Breakthrough Device designation to Natera’s Signatera test

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FDA has granted Breakthrough Device designation to Natera Inc.’s Signatera test for use in the post-surgical detection and quantification of circulating tumor DNA in the blood of patients previously diagnosed with certain types of cancer and in combination with certain drugs. The designation will help accelerate FDA assessment and review of Signatera as an in vitro diagnostic for use in pharmaceutical trials.

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