Burning Rock Receives CE Mark for its OverC™ Multi-Cancer Detection Blood Test Kit

Rhea-AI Summary

Burning Rock Biotech Limited (NASDAQ: BNR) announced it has received CE marking for its OverC™ Multi-Cancer Detection Blood Test, produced in the US and China. This test uses next-generation sequencing to detect DNA methylation markers in cfDNA from blood, aimed at early cancer detection in adults aged 40-75. The CE mark validates the quality management system in its labs and supports the company's global business strategy. The OverC™ test leverages the ELSA-seq technology, which combines epigenetics, NGS, and machine learning for efficient tumor DNA detection, marking a significant milestone in cancer diagnostics.

Positive

• Received CE marking for OverC™ Multi-Cancer Detection Blood Test, enhancing market credibility.
• Validates quality management systems in US and China laboratories, supporting international operations.
• Utilizes advanced ELSA-seq technology for efficient early cancer detection, potentially broadening market applications.

Negative

• None.

SHANGHAI, June 1, 2022 /PRNewswire/ -- 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.

About Burning Rock

Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of 1) NGS-based therapy selection testing for late-stage cancer patients, 2) Global pharmaceutical services on biomarker detection and companion diagnostics developing, and 3) NGS-based cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.

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SOURCE Burning Rock

FAQ

What is the OverC™ Multi-Cancer Detection Blood Test by Burning Rock (BNR)?

The OverC™ Multi-Cancer Detection Blood Test is a blood test that uses next-generation sequencing to detect DNA methylation markers, aimed at early cancer detection in adults aged 40-75.

When did Burning Rock receive CE marking for its OverC™ test?

Burning Rock received CE marking for its OverC™ Multi-Cancer Detection Blood Test on June 1, 2022.

How does the ELSA-seq technology work in the OverC™ test?

ELSA-seq technology combines epigenetics, next-generation sequencing, and machine learning to identify trace amounts of circulating tumor DNA methylation signals in blood.

What does the CE mark signify for Burning Rock's OverC™ test?

The CE mark signifies that the OverC™ test meets European safety and efficacy standards, supporting its commercialization in the region.

What age group is targeted by the OverC™ Multi-Cancer Detection Blood Test?

The OverC™ test is intended for adults aged 40-75 years old for early cancer detection.