FDA grants Breakthrough Device designation to Natera's Signatera test

May 8, 2019

Natera, Inc. announced that the FDA has granted "Breakthrough Device" designation for its Signatera test for use in the post-surgical detection and quantification of circulating tumor DNA (ctDNA) 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.

Signatera is a ctDNA test custom-built for each patient based on the unique mutations in an individual patient's tumor. Signatera has been shown in numerous clinical studies, across non-small cell lung, bladder, breast and colorectal cancers, to identify molecular residual disease significantly earlier (up to two years earlier) than standard imaging. Studies have also shown that Signatera test status is a significant predictor of long-term patient outcomes after surgery and treatment, relative to all other clinical and pathological factors.

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