Burning Rock Received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test

Rhea-AI Summary

Burning Rock (NASDAQ/LSE: BNR), based in Irvine, California, has announced that its OverC™ Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US FDA, marking it as the third globally to receive this recognition. This designation supports the rapid development and review of medical devices for serious conditions like cancer. The OverC™ MCDBT targets early detection of multiple cancers, showing a 69.1% sensitivity and 98.9% specificity in preliminary studies. The technology aims to enhance early diagnosis and treatment efficiency, potentially improving patient survival rates.

Positive

• FDA Breakthrough Device Designation for OverC™ MCDBT enhances development and review timeline.
• Demonstrated 69.1% sensitivity and 98.9% specificity in cancer detection.
• OverC™ MCDBT targets multiple hard-to-screen cancers, adding significant value to cancer diagnostics.

Negative

• None.

IRVINE, Calif., Jan. 3, 2023 /PRNewswire/ -- Burning Rock (NASDAQ/LSE: BNR), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today announced that its OverC™ Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

Under the FDA's Breakthrough Devices Program, the Breakthrough Device Designation is granted to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions such as cancer. This program is designed to provide patients and healthcare providers with timely access to medical devices granted the designation by speeding up their development, assessment, and review.

OverC™ MCDBT is intended for early detection of multiple cancer types (esophageal, liver, lung, ovarian, and pancreatic cancers) in adults of either sex, aged 50-75 years old, at average risk for cancer. OverC™ MCDBT demonstrated a 69.1% of sensitivity and 98.9% of specificity in the case-control study, THUNDER, and will be further validated in prospective interventional studies among asymptomatic population. Test results of "Detected" with the top one or two predicted tissues of origin of cancer-associated signals may indicate the presence of cancer and should be followed up by diagnostic tests suggested by qualified healthcare professionals in accordance with professional guidelines. Test results of "Undetected" do not rule out the presence of cancer, and individuals should continue with guideline-recommended standard of care screening tests.

Compared with conventional cancer screening methods, liquid biopsy has the potential to increase detection efficiency and enable early diagnosis and treatment, thus improving patients' survival and quality of life while reducing social burden of the disease. Burning Rock started development of multi-cancer early detection technology based on DNA methylation in 2016, and the technology and validation data have been presented at ASCO, ESMO and other medical conferences, as well as journals such as Nature Biomedical Engineering ^[1], demonstrating high specificity, sensitivity, and accuracy in predicting the tissue of origin. In May 2022, Burning Rock received CE mark for its OverC™ MCDBT manufactured in both the US and China facilities. Today, the FDA Breakthrough Device Designation granted for OverC™ MCDBT would pave the way for a clearer registration path through confirmative performance validation and utility establishment.

Mr. Yusheng Han, founder and CEO of Burning Rock, said, "We are very excited that our cfDNA methylation multi-cancer early detection technology has received FDA Breakthrough Device Designation. For cancer, early diagnosis and treatment are the key to the long-term survival of patients. Liquid biopsy-based early detection technology will be an important supplement to the current cancer screening methods, especially for ovarian cancer, pancreatic cancer and other cancers that have no effective screening methods up to now. Burning Rock has also launched two prospectively collected case-control studies, PREDICT and PRESCIENT, with more than 10,000 subjects to be enrolled, to continue developing OverC™ MCDBT to cover more cancer types. With our promising clinical research data, we believe that over time our collective effort is going to make significant impact towards the improvement of cancer patients' lifespan and quality of life."

Reference

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

View original content:https://www.prnewswire.com/news-releases/burning-rock-received-fda-breakthrough-device-designation-for-its-overc-multi-cancer-detection-blood-test-301712390.html

SOURCE Burning Rock

FAQ

What is the significance of the Breakthrough Device Designation for BNR's OverC™ MCDBT?

The Breakthrough Device Designation accelerates the development and review of OverC™ MCDBT, facilitating quicker access to this innovative cancer detection test.

What are the sensitivity and specificity of the OverC™ Multi-Cancer Detection Blood Test?

The OverC™ MCDBT showed 69.1% sensitivity and 98.9% specificity in its case-control study THUNDER.

What cancers does the OverC™ MCDBT test aim to detect?

The OverC™ MCDBT is designed for early detection of esophageal, liver, lung, ovarian, and pancreatic cancers.

When did Burning Rock receive the FDA Breakthrough Device Designation?

Burning Rock received the FDA Breakthrough Device Designation on January 3, 2023.