Burning Rock Biotech has obtained CE mark for its OverC Multi-Cancer Detection Blood Test, a qualitative next-generation sequencing (NGS)-based in vitro diagnostic device.
Manufactured in the US and China facilities, the device has been designed to detect DNA methylation markers using cfDNA from human peripheral whole blood.
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The OverC assay has been developed for earlier detection and localisation of multiple types of cancer in adult patients aged 40 to 75 years.
Burning Rock’s self-developed multi-cancer early detection technology, ELSA-seq, has been used in the new device, which comprises a sequencing instrument used for massively parallel sequencing (MPS) of pooled libraries.
The assay also includes software for the analysis of data; as well as a semi-automated workflow that includes preparation of libraries and extraction of cfDNA.
The company noted that the ELSA-seq technology has combined NGS, machine learning and epigenetics for the early detection of multiple cancer types.
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By GlobalDataIt noted that the technology has accomplished the efficient capture of tracing circulating tumour DNA methylation signals in blood.
Burning Rock Biotech said in a statement: “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 achievement ushers in a new phase in the company’s history for the early detection of cancer.”
The company’s business includes Global pharmaceutical services to detect biomarker and develop companion diagnostics; NGS-based therapy selection testing for late-stage cancer patients; and NGS-based early cancer detection.
