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.
Leadership is changing at The Wistar Institute and the Helen F. Graham Cancer Center & Research Institute in the months to come—but the leaders of the two institutions say that this will have little if any effect on the clinical-research collaboration that they have spent the past 15years building (The Cancer Letter, July 12, 2019).
