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News
Natera's multi-cancer early detection (MCED) blood test just got a major regulatory boost. The FDA granted it Breakthrough Device Designation after reviewing data across 12 cancer types, recognizing its potential to catch cancers earlier — when they're most treatable. The designation unlocks faster FDA review and closer collaboration during development, though it doesn't mean the test is approved yet.
The FDA has granted Breakthrough Device Designation to Natera's multi-cancer early detection (MCED) assay — a blood-based test that scans cell-free DNA (cfDNA) for cancer signals and can predict where in the body a cancer likely originated. The designation was awarded after the FDA reviewed the assay's performance data across 12 cancer types, evaluating its sensitivity, specificity, and cancer signal origin (CSO) accuracy. Natera says the results were compelling, though specific figures weren't disclosed.
This designation doesn't mean the test is approved — but it does open the door to faster, more collaborative FDA review and prioritized evaluation of future premarket submissions. No MCED test has received FDA approval yet, though rival GRAIL's Galleri test recently cleared an FDA advisory committee vote and remains under agency review.
Natera is also developing a separate blood-based colorectal cancer (CRC) screening test, which has shown 95% sensitivity for CRC overall and 91% specificity in prospective case-control data, and is now being validated in the 25,000-participant FIND-CRC study.
By the Numbers:
Why it matters: Too many cancers are caught late, when treatment options are limited. A validated, blood-based multi-cancer screening tool could transform early detection — and the FDA's Breakthrough designation signals the agency sees real promise in Natera's approach.
