Multi-Cancer Blood Test Receives FDA Breakthrough Designation

Finding cancer early is one of the biggest challenges in medicine today. Many cancers go unnoticed until they are hard to treat, mostly because doctors lack easy ways to screen for them.

A company called Natera, Inc. seeks a solution using its multi-cancer early detection (MCED) assay.

Natera received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the new early detection assay. The blood test looks for cell-free DNA to detect multiple cancers at once.

The FDA gives this special status to novel technologies that help diagnose or treat life-threatening conditions. To make its decision, the FDA reviewed data from 12 different cancer types. The agency reviewed how well the test detects cancer, its accuracy, and its ability to pinpoint where the cancer started in the body. According to doctors, the test delivered strong results across the board.

Early Cancer Detection Gives Patients a Better Chance of Survival

This new status gives Natera a direct path to work more closely with regulators and, eventually, to secure approval for the MCED assay. The Breakthrough Devices program aims to give patients and doctors faster access to new medical tools. Additionally, it accelerates the development, review, and assessment steps required for full approval, 510(k) clearance, or marketing authorization.

According to the World Health Organization (WHO), earlier detection improves patients’ chances of survival and offers a much better shot at successful treatment.

“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.”