A precision test that combines image analysis and biomarkers might change how clinicians monitor cancer risk in patients with Barrett’s esophagus. A single-blinded, case–control study found that the test (TissueCypher, Cernostics) was highly sensitive at identifying nondysplastic Barrett’s at high risk for progression.
The laboratory developed test, a class of products over which the FDA has regulatory authority but generally has not required premarket approval, is performed on