Burning Rock secures FDA breakthrough device designation for multicancer blood test
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The FDA has granted breakthrough device designation to Burning Rock’s OverC multicancer blood test for early detection of esophageal, liver, lung, ovarian and pancreatic cancers, according to a company press release.
Intended for use in adults aged 50-75 years at average risk for cancer, the OverC liquid biopsy test may allow increased detection efficiency and enable early diagnosis and treatment compared with conventional cancer screening methods, according to the release.
“We are very excited that our [cell-free] DNA methylation multicancer early detection technology has received FDA breakthrough device designation,” Yusheng Han, founder and CEO of Burning Rock, said in the 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.”
The FDA based its decision on data from the THUNDER case-control study, in which the blood demonstrated 69.1% sensitivity and 98.9% specificity. These findings will be further validated in prospective interventional studies in an asymptomatic population.
A ‘detected’ result from the OverC test may indicate the presence of cancer and should be followed up by diagnostic tests; however, an ‘undetected’ result does not necessarily rule out the presence of cancer, and individuals should continue with guideline-recommended standard of care screening tests.
“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 [multi-cancer blood test] to cover more cancer types,” Han said. “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.”
Breakthrough device designation is granted to accelerate development and regulatory review of investigational drugs that are intended to treat serious or life-threatening diseases and conditions.