Jordan Stricker, Director of Strategic Oncology Collaborations at Natera, shared on LinkedIn:
“Today the FDA granted Breakthrough Device designation to Natera’s multi-cancer early detection assay.
That is not a marketing authorization. It means a blood test built on cell-free DNA met the agency’s bar for a novel technology aimed at a life-threatening condition, and that development, assessment, and review now move on a faster path.
The designation rested on data across 12 cancer types, and on the three measures that decide whether a screening test is actually useful: sensitivity, specificity, and cancer signal origin. A signal without a credible origin sends patients into the wrong workup. Origin without sensitivity misses the cancers that still have no guideline screen. The assay generated compelling results on all three.
Too many cancers are still diagnosed after they have progressed, simply because screening options remain limited. The point of this program is to find them earlier, when they are easier to treat.
Natera has spent years reading trace signals in blood. Extending that platform into screening is the work this designation accelerates”
More about this topic: Natera’s Multi-Cancer Early Detection Assay Receives FDA Breakthrough Designation, Targeting Screening Gaps
