FDA gives Natera breakthrough status for multi-cancer blood test

The FDA granted breakthrough device designation to Natera’s multi-cancer early detection assay, a blood-based test that analyzes cell-free DNA to screen for multiple cancers. The agency reviewed data spanning 12 cancer types and assessed sensitivity, specificity and cancer signal origin performance, but Natera did not disclose the specific cancer types, study population or performance figures.

The designation gives Natera access to more interactive communication with FDA experts during development and prioritized review of future premarket submissions, including premarket approval applications, 510(k) clearances and de novo requests. It does not amount to FDA clearance or approval.

Natera’s assay is designed to identify a cancer signal in circulating cell-free DNA and predict where the cancer likely originated, helping guide follow-up diagnostic work. No multi-cancer early detection test had FDA approval at the time of the announcement. On September 23, 2026, an FDA advisory panel backed GRAIL’s Galleri test for adults aged 50 years and older, voting 7 to 2 with 1 abstention that benefits outweighed risks and 6 to 4 in support of effectiveness.