Burning Rock nabs FDA breakthrough device designation for multicancer detection blood test

Liquid biopsy oncology firm Burning Rock said on Tuesday that the U.S. Food and Drug Administration (FDA) has granted breakthrough device designation for its OverC Multi-Cancer Detection Blood Test (MCDBT).

OverC MCDBT is intended for early detection of esophageal, liver, lung, ovarian, and pancreatic cancers in adults of either sex from 50 to 75 years of age who are at average risk for cancer.

Burning Rock noted that the test has demonstrated a sensitivity of 69.1% and specificity of 98.9% in a case-controlled study called THUNDER, and will be further validated in prospective interventional studies involving asymptomatic individuals. 

Test results showing "detected" may indicate the presence of cancer. Such results should be followed up by diagnostic tests suggested by qualified healthcare professionals in accordance with professional guidelines, Burning Rock said. Test results showing "undetected" do not rule out the presence of cancer, and individuals should continue with guideline-recommended standard-of-care screening tests.

Burning Rock noted that it started development of multicancer early detection technology based on DNA methylation in 2016, and the technology and validation data have been presented at medical conferences and in peer-reviewed journals such as Nature Biomedical Engineering, demonstrating high specificity, sensitivity, and accuracy in predicting the tissue of origin.

In May 2022, the company received the CE Mark for OverC MCDBT. The test is manufactured at its facilities in the U.S. and China.