FDA grants Breakthrough Device Designation for Burning Rock’s multi-cancer detecting test
pharmafile | January 4, 2023 | News story | Medical Communications |
Burning Rock, a Chinese biotech company which focuses on the applications of next-generation sequencing (NGS) technology in the field of precision oncology, has secured the FDA Breakthrough Device for its OverC Multi-Cancer Detection Blood Test (MCDBT).
OverC MCDBT was developed based on DNA methylation technology and is designed for the early detection of multiple cancers such as esophageal, liver, lung, ovarian and pancreatic cancers in adults aged 50-75 years. This liquid biopsy method has shown to have the potential to increase detection efficiency and enable an earlier diagnosis and subsequent treatment, compared to traditional screening methods.
In the THUNDER case-control study, OverC MCDBT showed a 69.1% sensitivity rate and 98.9% specificity rate. However, Burning Rock aims to continue to validate the test in interventional studies among the asymptomatic population.
Burning Rock founder and CEO Yusheng Han stated: “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 a significant impact towards the improvement of cancer patients’ lifespan and quality of life.”
James Spargo
