Burning Rock (Nasdaq:BNR) announced today that the FDA granted breakthrough device designation to its OverC blood test.
Irvine, California-based Burning Rock developed OverC as a multi-cancer detection blood test (MCDBT). It designed the test to detect cancer types including esophageal, liver, lung, ovarian and pancreatic cancers. Adults of either sex, aged 50-75 years old, at average risk for cancer may comprise the target population for the test.
According to a news release, OverC demonstrated 69.1% sensitivity and 98.9% specificity in a case-control study. Burning Rock intends to further validate the test in prospective interventional studies among an asymptomatic population.
Test results registered as “Detected” may indicate the presence of cancer. Patients should follow up that result with diagnostic tests suggested by qualified healthcare professionals. Tests that come in as “Undetected” do not rule out the presence of cancer, Burning Rock said.
Liquid biopsy could increase detection efficiency and enable early diagnosis and treatment, Burning Rock said. The company received CE mark for OverC in May 2022.
“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,” said Burning Rock founder and CEO Yusheng Han. 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.”