Geneseeq receives FDA Breakthrough Designation for Novel CanScan™ Multi-cancer Detection Solution
Geneseeq recently announced that its multi-cancer early detection solution, CanScan™, has received Breakthrough Device Designation from the US Food and Drug Administration (FDA). CanScan™ utilizes low-depth whole-genome sequencing (WGS) on circulating cell-free DNA (cfDNA) from a single tube of peripheral blood.
By extracting genetic and fragmentomic features, it detects early cancer signals with 99% specificity and predicts the tissue of origin (TOO) of cancers, offering guidance for subsequent diagnostic steps. The technology shows significant promise in addressing unmet medical needs for individuals aged 50 and above with an average risk of cancer. Notably, it outperforms current standard screening methods in common cancer types like prostate, lung, and liver cancers.
Additionally, CanScan™ is effective in detecting cancer types that lack efficient standard screening methods, such as esophagus, endometrial, gastric, pancreatic cancers, and lymphoma. The FDA's Breakthrough Device Designation comes on the heels of the CE approval of the CanScan™ assay kit.
