FDA grants breakthrough device designation to Natera's cancer detection test

Natera, Inc. (NASDAQ: NTRA) announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its multi-cancer early detection assay, a blood-based test designed to screen for multiple cancer types.

The designation applies to novel technologies intended to enable more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions. The FDA evaluated data from 12 cancer types, examining the test's sensitivity, specificity, and cancer signal origin performance before granting the designation.

Natera's assay analyzes cell-free DNA in the blood to detect cancer signals. The Breakthrough Devices program is intended to speed up development, assessment, and regulatory review for devices that meet its criteria, with the goal of providing patients and healthcare providers with timely access to medical devices.

Alexey Aleshin, M.D., Natera's chief medical officer and general manager of oncology and early cancer detection, said: "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."

Natera is based in Austin, Texas, and operates laboratories certified under the Clinical Laboratory Improvement Amendments.

You May Also Be Interested In

• AstraZeneca launches sunvozertinib for EGFR exon 20 NSCLC
• BlackSky wins expanded defense contract with international partner
• Alpha Tau signs MOU with Samsung Medical Center for pancreatic cancer trial