Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) announced that it has received CE marking for its OverC™ Multi-Cancer Detection Blood Test manufactured in both the US and China facilities (Identification Number: DE/CA20/01-IVD-Luxuslebenswelt-523/22, DE/CA20/01-IVD-Luxuslebenswelt-524/22).

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.

The receipt of CE mark demonstrates the consistency of the quality management systems across Burning Rock’s US and China laboratories, and will further promote the company’s global business strategy.

The OverC™ test is based on Burning Rock’s self-developed multi-cancer early detection technology ELSA-seq. Since 2016, Burning Rock has been committed to promote innovation-driven development, and implement the strategy for early cancer detection. The technology has combined epigenetics, NGS, and machine learning to achieve multi-cancer early detection. ELSA-seq has successfully accomplished the efficient capture of trace amounts of circulating tumor DNA methylation signals in blood.

ELSA-seq has been published in a number of high-impact academic journals ^[1-4]. These results demonstrate that ELSA-seq is a highly sensitive test for detection of the trace amounts of tumor-derived methylation signals in plasma samples from multiple cancer types.

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.

References

[1] Luo, B., Ma, F., Liu, H. et al. Cell-free DNA methylation markers for differential diagnosis of hepatocellular carcinoma. BMC Med 20, 8 (2022). https://doi.org/10.1186/s12916-021-02201-3

[2] Qiao, G., et al., Discovery and validation of methylation signatures in circulating cell-free DNA for early detection of esophageal cancer: a case-control study. BMC Med, 2021. 19(1): p. 243.

[3] Liang, N., et al., Ultrasensitive detection of circulating tumour DNA via deep methylation sequencing aided by machine learning. Nat Biomed Eng, 2021. 5(6): p. 586-599.

[4] Sui, J., et al., Discovery and validation of methylation signatures in blood-based circulating tumor cell-free DNA in early detection of colorectal carcinoma: a case-control study. Clin Epigenetics, 2021. 13(1): p. 26.