FDA grants breakthrough device designation to Natera's cancer detection test

Go back to FDA grants breakthrough device designation to Natera's cancer detection test

FDA Grants Breakthrough Device Designation for Natera’s Multi-Cancer Early Detection Assay

October 9, 2026 8:00 AM EDT

Designation supports the development of a blood-based assay intended to screen for various cancers

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that its multi-cancer early detection (MCED) assay has been granted Breakthrough Device designation (BDD) by... More