The FDA has granted Breakthrough Device designation to Natera's experimental multi-cancer early detection blood test, the company announced Oct. 9. The designation is not an FDA approval or clearance. The test still has to meet the agency's full safety and effectiveness standards before it can be marketed with FDA authorization.
The test looks for signs of cancer in cell-free DNA, the small fragments of genetic material that tumors shed into the bloodstream. When it finds a signal, it also tries to predict where in the body the cancer started. Natera said the FDA reviewed data covering 12 cancer types, but the company did not release sensitivity, specificity, or other accuracy figures, according to OncLive.
