FDA Grants Breakthrough Device Designation to OverC Multi-Cancer Detection Blood Test

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

In findings from the THUNDER case-control study, OverC^™ MCDBT demonstrated a 69.1% rate of sensitivity and 98.9% rate of specificity. In data from 308 patients with surgery-resectable lung cancer and 261 age- and sex-matched non-cancer controls published in 2021, the assay detected 52% to 81% of patients at disease stages IA to III with a specificity rate of 96% (95% CI, 93%-98%).²

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

Investigators will further validate the assay in prospective interventional studies in an asymptomatic population.

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

Liquid biopsy has the potential to improve cancer detection, early diagnosis and treatment compared with conventional cancer screening methods, leading to improved survival and quality of life while reducing other disease-related burdens.

Burning Rock started development of multi-cancer early detection technology based on DNA methylation in 2016. The technology and validation data have been presented at ASCO, ESMO and other medical conferences, as well as journals such as Nature Biomedical Engineering, demonstrating high specificity, sensitivity, and accuracy in predicting the tissue of origin.

Test results of “Detected” with the top 1 or 2 predicted tissues of origin of cancer-associated signals could signal the presence of cancer. Patients should follow up with diagnostic tests provided by health care professionals in accordance with professional guidelines.

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

“Burning Rock has also launched two prospectively collected case-control studies, PREDICT [NCT04817306] and PRESCIENT [NCT04822792], 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,” Han concluded.

References

1. Burning Rock received FDA breakthrough device designation for its OverC^™ multi-cancer detection blood test. News release. Burning Rock. January 3, 2022. Accessed January 4, 2022. https://prn.to/3QbJeNc
2. Liang N, Li B, Jia Z, Wang C, et al. Ultrasensitive detection of circulating tumour DNA via deep methylation sequencing aided by machine learning. Nat Biomed Eng. 2021;5(6):586-599. doi:10