FDA Grants Breakthrough Device Designation to Natera’s Multi-Cancer Early Detection Assay
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Natera has received FDA Breakthrough Device Designation for its multi-cancer early detection assay, designed to screen for multiple cancers using cell-free DNA.
Natera’s blood-based, cell-free DNA multi-cancer early detection assay received the designation after the FDA reviewed data spanning 12 cancer types. The FDA has granted breakthrough device designation to Natera’s multi-cancer early detection (MCED) assay, a blood-based test that analyzes cell-free DNA (cfDNA) to screen for multiple cancers.
In granting the designation, the FDA assessed data from 12 cancer types and evaluated the assay’s sensitivity, specificity, and cancer signal origin (CSO) performance. Natera stated that the assay generated compelling results across these measures to support the designation. The news release did not report specific sensitivity, specificity, or CSO accuracy figures, nor did it identify the 12 cancer types or the study population from which the data were drawn.
Too many cancers are diagnosed after they’ve progressed, simply because limited screening options exist,” said Alexey Aleshin, MD, corporate chief medical officer and general manager of oncology and early cancer detection at Natera, in the news release. “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.”
The FDA’s Breakthrough Devices Program is a voluntary program for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases and that meet at least one additional criterion, such as representing breakthrough technology, having no approved or cleared alternatives, or offering significant advantages over existing approved or cleared alternatives.
Designated devices are eligible for interactive communication with FDA experts during development and for prioritized review of premarket submissions, including premarket approval (PMA) applications, 510(k) clearances, and de novo requests. The designation does not constitute FDA clearance or approval of the assay.
