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.

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.

It 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.