The FDA has granted Breakthrough Device designation to a new blood-based test from Natera that analyzes cell-free DNA to screen for multiple cancers.
Natera said in an Oct. 9 statement that in granting the breakthrough status, the FDA assessed data from 12 cancer types and considered the test’s sensitivity, specificity, and performance on determining cancer signal origin. However, the company did not disclose the underlying results, the test’s name, how many cancer types it is designed to detect, or a development or launch timeline.
“Too many cancers are diagnosed after they’ve progressed, simply because limited screening options exist,” Alexey Aleshin, Natera’s chief medical officer and general manager of oncology and early cancer detection, suggesting that the designation reflected “the rigor and promise of our MCED program.”