Cell-free DNA and precision medicine company Natera Inc (NASDAQ:NTRA) announced on Friday that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to its multi-cancer early detection (MCED) assay, supporting development of a blood-based test designed to screen for multiple cancers.

The FDA evaluated data covering 12 cancer types, including sensitivity, specificity and cancer signal origin performance.

Breakthrough Device designation recognises echnologies intended to improve the diagnosis or treatment of life-threatening or irreversibly debilitating conditions.

Natera said this designation supports its MCED programme and its efforts to detect cancer earlier, when treatment may be more effective.

The FDA's Breakthrough Devices programme aims to accelerate device development, assessment and regulatory review to facilitate timely patient and healthcare provider access.