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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.