FDA Grants Breakthrough Device Designation for Natera’s Multi-Cancer Early Detection Assay
Natera's multi-cancer early detection (MCED) assay received FDA Breakthrough Device designation, supporting faster development and review for premarket approval or marketing authorization. The designation was based on data across 12 cancer types, with the FDA citing sensitivity, specificity, and cancer signal origin performance.
Key figures
- Drug Name
- multi-cancer early detection (MCED) assay
- Cancer types assessed
- 12
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