Geneseeq, a biotech company, has announced that its revolutionary multi-cancer early detection solution, CanScan™, has received Breakthrough Device Designation from the US Food and Drug Administration (FDA). 

This cutting-edge technology utilizes low-depth whole-genome sequencing on circulating cell-free DNA, demonstrating an impressive 99 percent specificity in identifying early cancer signals and predicting the tissue of origin (TOO) for cancers.

CanScan™ holds significant promise in addressing unmet medical needs, particularly in clinical diagnosis and treatment for individuals aged 50 and above with an average risk of cancer.

The system has showcased superior performance compared to current standard of care (SOC) screening methods, excelling in detecting common cancer types such as prostate, lung, and liver cancers. 

Importantly, CanScan™ also identifies cancer types currently without effective SOC screening methods, including esophageal, endometrial, gastric, pancreatic cancers, and lymphoma.

Built on Geneseeq's highly sensitive MERCURY™ multi-omics technology, CanScan™ has undergone rigorous validation in the DECIPHER (Detecting Early Cancer by Inspecting ctDNA Features) clinical study series across over thirteen cancer types. 

Currently, CanScan™ is undergoing real-world evaluation in the Jinling Cohort, a large-scale prospective multi-center trial. The ongoing recruitment of 15,000 individuals for the phase I trial within the Jinling Cohort is nearing completion.

Dr. Xue Wu, CEO of Geneseeq Toronto, emphasized the significance of the Jinling Cohort in further validating CanScan™'s technical performance within the targeted screening population. Dr. Wu stated that more results from the Jinling Cohort would be released in 2024.

This FDA Breakthrough Device Designation adds to CanScan™'s accolades, following its CE approval in January 2023, marking another significant recognition from an internationally authoritative institution.