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OverC™ Multi-Cancer Detection Blood Test is a qualitative next-generation sequencing (NGS)-based in vitro diagnostic device for the detection of DNA methylation markers using cfDNA isolated from human peripheral whole blood. It is intended for earlier detection and localization of multiple cancer types in adults of either sex, aged 40-75 years old. The OverC™ assay includes a semi-automated workflow including cfDNA extraction and library preparation; a sequencing instrument for massively parallel sequencing (MPS) of the pooled libraries; as well as an analysis software for data analysis. Data analysis output includes classification calls for cancer signal.
Next-Generation Sequencing (NGS)