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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I write a weekly blog for Georgetown University’s Lombardi Comprehensive Cancer Center community. Here I share an updated version of a blog post I wrote in September 2024, now supplemented by some poems I have written over the years that inspired paintings by my wife Harriet Weiner, who is a much better artist than I am a poet or writer. 

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