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Geneseeq scores FDA breakthrough designation for cancer detection device

January 4, 2024

The US Food and Drug Administration (FDA) has granted breakthrough device designation to CanScan, the multi-cancer early detection solution by Canadian medtech Geneseeq.

CanScan was built using Geneseeq’s highly sensitive MERCURY multi-omics technology. The solution uses low-depth whole-genome sequencing (WGS) on circulating cell-free DNA (cfDNA) present in peripheral blood to detect cancer. The genetic and fragmentomic features of the cfDNA are used to detect early cancer signals with 99% specificity and predict the tissue of origin of cancers.

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