Multi-Cancer Screening Blood Test Gains FDA Breakthrough Designation

Natera Inc.’s (Austin, TX, USA) multi-cancer early detection (MCED) assay has received Breakthrough Device designation (BDD) from the U.S. Food and Drug Administration (FDA). The assay analyzes cell-free DNA in blood to screen for multiple cancers. The designation is intended for novel technologies that enable more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions.

The FDA considered data from 12 cancer types in granting the designation. The assessment included sensitivity, specificity, and cancer signal origin (CSO) performance. Numerical performance values were not provided, but the test was described as generating results that supported the designation.

The FDA’s Breakthrough Devices program is intended to provide patients and healthcare providers with timely access to medical devices. It is designed to speed development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Devices must meet rigorous criteria to qualify for the program.

“Too many cancers are diagnosed after they’ve progressed, simply because limited screening options exist. 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,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager, oncology and early cancer detection, Natera.

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