Written by Emil Luca: Burning Rock announced that it has received CE marking for its OverC Multi-Cancer Detection Blood Test.
Early detection and treatment are crucial for cancer control. OverC Multi-Cancer Detection Blood Test is intended for earlier detection and localization of multiple cancer types in adults of either sex, aged 40-75 years old.
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 (cell-free DNA) isolated from human peripheral whole blood. The 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.
The technology has combined epigenetics, NGS, and machine learning to achieve multi-cancer early detection. It has successfully accomplished the efficient capture of trace amounts of circulating tumor DNA methylation signals in plasma samples from multiple cancer types.
The CE mark indicates that the product may be sold freely in any part of the European Economic Area. The approval of CE mark for the OverC test is of much significance for the commercialization and compliance process of Burning Rock’s multi-cancer early detection technology and marks a breakthrough in the company’s global business strategy.
This new test is another addition to the blood tests for early cancer detection and diagnosis. It is another step towards the control of cancer and curbing its grave health and economic burden. Early diagnosis and personalized therapy are now the keys towards this goal.
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The writer declares no conflict of interest. Specific information about this product are obtained from the manufacturer’s website. Inquiries are to be addressed to the manufacturer.