Test for Circulating Tumor DNA Wins FDA Breakthrough Designation
June 5, 2019FDA has granted breakthrough device designation for Natera’s test to detect and quantify circulating tumor DNA (ctDNA) after surgery in the blood of patients already diagnosed with some types of cancer and combined with certain drugs, Natera said Monday.
Natera said the FDA breakthrough designation will help support the company’s commercialization strategy by speeding assessment and review of Signatera as an in vitro diagnostic for use in pharmaceutical trials. The company said it sees the test being used in the patient selection process among other study functions.