FDA Grants Breakthrough Designation for OverC™ MCDBT to Detect Early Cancers


The THUNDER case-control study elicited a 69.1% rate of sensitivity and 98.9% rate of specificity with the OverC™ MCDBT in adult patients with various cancers.

The FDA has granted breakthrough device designation to the OverC Multi-Cancer Detection Blood Test (MCDBT) to aid in the early detection of esophageal, liver, lung, ovarian, and pancreatic cancers in adult patients aged to 50 to 75 years with average risk, according to Burning Rock.1

Findings come from the THUNDER case-control study where OverC MCDBT led to a 69.1% rate of sensitivity and 98.9% rate of specificity. OverC MCDBT will be further evaluated in prospective interventional studies in an asymptomatic patient population.

“We are very excited that our cell-free DNA methylation multi-cancer early detection technology has received FDA breakthrough device designation,” said Yusheng Han, founder and chief executive officer of Burning Rock, in a press release. “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.”

A liquid biopsy can potentially improve cancer detection, early diagnosis, and treatment for patients, compared with conventional cancer screening methods. With this development, experts may be able to improve their patients’ survival rates, quality of life, and reduce other disease-related burdens.

According to data published in Nature in 2021, 308 patients with surgery-resectable lung cancer and 261 age- and sex-matched non-cancer controls were evaluated. Findings revealed the assay detected that 52%-81% of patients at disease stages IA to III with a specificity rate of 96% (95% CI, 93%-98%).2

The assay also identified nearly twice as many patients with cancer as those detected by ultradeep mutation sequencing analysis when evaluating a subgroup analysis which included 115 participants. The specificity rate was 100% (95% CI, 91%-100%).2

The development of multi-cancer early detection technology based on DNA methylation by Burning Rock began in 2016. Data regarding the technology and validation of the device have shown high specificity, sensitivity, and accuracy in predicting the tissue of origin. These data have previously been presented at the American Society of Clinical Oncology and European Society for Medical Oncology meetings, other medical conferences, and published in journals.

According to the press release, OverC™ MCDBT could signal the presence of cancer by test results of “Detected” with the top 1 or 2 predicted tissues of origin of cancer-associated signals. Follow-up with diagnostic tests provided by health care professionals in accordance with professional guidelines is recommended for these patients.

Test results of “Undetected” do not indicate the absence of cancer and healthy individuals should continue with guideline-recommended standard of care screening tests.

“Burning Rock has also launched 2 prospectively collected case-control studies, PREDICT [NCT04817306] and PRESCIENT [NCT04822792], with more than 10,000 subjects to be enrolled, to continue developing OverCMCDBT to cover more cancer types. With our promising clinical research data, we believe that over time our collective effort is going to make a significant impact towards the improvement of cancer patients’ lifespan and quality of life,” concluded Han.

  1. Burning Rock received FDA breakthrough device designation for its OverCmulti-cancer detection blood test. News release. Burning Rock. January 3, 2022. Accessed January 4, 2023. https://prn.to/3QbJeNc
  2. Liang N, Li B, Jia Z, Wang C, et al. Ultrasensitive detection of circulating tumor DNA via deep methylation sequencing aided by machine learning. Nat Biomed Eng. 2021;5(6):586-599. doi:10.1038/s41551-021-00746-5. Epub 2021 Jun 15.
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