Multi-Cancer Screening Blood Test Gets Breakthrough Device Status

Burning Rock has received the FDA’s Breakthrough Device designation for its OverC MCDBT cancer screening blood test for esophageal, liver, lung, ovarian and pancreatic cancers.

The liquid biopsy provides early detection in adults between the ages of 50 and 75 who are at average risk of getting cancer. A positive result may indicate the presence of cancer and should be followed up by confirmatory diagnostic tests.

The test’s Breakthrough Device status will provide “a clearer registration path through confirmative performance validation,” the company said.

The cancer screening test gained the CE mark in May 2022.