Burning Rock’s Multi-Cancer Blood Test Gains Breakthrough Status

Burning Rock, a company applying next-generation sequencing (NGS) tech in precision oncology, has been granted breakthrough status from the U.S. Food and Drug Administration for its OverC multi-cancer detection blood test (MCDBT).
 
OverC MCDBT aims to detect multiple cancer types (esophageal, liver, lung, ovarian, and pancreatic cancers) in adults of either sex, aged 50-75, at average cancer risk. The test showed a 69.1% sensitivity and 98.9% specificity in the THUNDER case-control study. It will be further validated in prospective interventional studies in an asymptomatic population.
 
Test results of “Detected” with the top one or two predicted tissues of origin of cancer-associated signals may show presence of cancer and should be followed up by diagnostic tests suggested by qualified clinicians according to professional guidelines. Test results of “Undetected” don’t rule out cancer presence and individuals should continue with guideline-recommended standard of care screening tests.
 
In May 2022, Burning Rock received CE mark for its OverC MCDBT manufactured in both its U.S. and China facilities. 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.
 
Yusheng Han, founder and CEO of Burning Rock, told the press, “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.”