FDA Grants Breakthrough Device Designation for Natera’s Multi-Cancer Early Detection Assay
Business Wire•09/10/2026•08:00 ET
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Key Highlights
- ➤Natera’s MCED assay receives FDA Breakthrough Device designation
- ➤FDA assessed data spanning 12 cancer types for the designation
- ➤Assay analyzes blood-based cell-free DNA to screen for multiple cancers
- ➤Designation may speed development and FDA review toward market authorization
Expert Statements
Alexey Aleshin, Corporate chief medical officer and general manager, oncology and early cancer detection, Natera
“Too many cancers are diagnosed after they’ve progressed, simply because limited screening options exist.”
Alexey Aleshin, Corporate chief medical officer and general manager, oncology and early cancer detection, Natera
“This designation underscores the rigor and promise of our MCED program, and we look forward to working with the FDA as we aim to detect cancer earlier, when it’s easier to treat.”
FDA Grants Breakthrough Device Designation for Natera’s Multi-Cancer Early Detection Assay
Designation supports the development of a blood-based assay intended to screen for various cancers
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