FDA Grants Breakthrough Device Designation for Natera’s Multi-Cancer Early Detection Assay

Original from: Natera

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that its multi-cancer early detection (MCED) assay has been granted Breakthrough Device designation (BDD) by the U.S. Food and Drug Administration (FDA). The BDD is designed for novel technologies that enable more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions.

Natera’s MCED assay analyzes cell-free DNA in the blood to screen for multiple cancers. In granting the BDD, the FDA assessed data from 12 cancer types and considered sensitivity, specificity, and cancer signal origin (CSO) performance. The test generated compelling results to support the designation.

“Too many cancers are diagnosed after they’ve progressed, simply because limited screening options exist,” said Alexey Aleshin, M.D., 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.”

The Breakthrough Devices program is intended to provide patients and healthcare providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Devices must meet rigorous criteria to earn the designation.

Source: FDA Grants Breakthrough Device Designation for Natera’s Multi-Cancer Early Detection Assay