By Blood Cancers Today Staff Writers - Last Updated: February 8, 2024
The FDA has granted Breakthrough Device Designation to CanScan, a multicancer early detection solution.
CanScan uses low-depth whole-genome sequencing on circulating cell-free DNA from a single tube of peripheral blood. It is able to detect early cancer signals with 99% specificity and predict the tissue of origin of cancers to help guide next steps for cancer diagnosis, according to Geneseeq, the manufacturer of the device.
The device detects cancer types currently without effective standard-of-care screening methods, including the blood cancer lymphoma.
The performance of CanScan has been validated in a large-scale clinical study series in over 13 cancer types, according to Geneseeq. CanScan is currently under real-world evaluation in the Jinling Cohort, a large-scale, prospective, multicenter trial.
Original Source: FDA Grants Breakthrough Device Designation for Multicancer Early Detection Solution | Blood Cancers Today