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.
Collage art of mammograms of dense breastsIllustrator: Cyrus FineganWhile breast cancer experts are anything but clear on what the words “dense breasts” signify in the clinic, or for that matter, in the English language, FDA appears to be less perplexed.
