Study Clinically Validates Multi-Cancer Early Detection Test
Sensitivity was 67.6 percent for Stage I to III disease for 12 prespecified cancers accounting for two-thirds of U.S. cancer deaths
FRIDAY, June 25, 2021 (HealthDay News) -- The multi-cancer early detection (MCED) test is feasible as a blood-based test that could be used to complement existing single-cancer screening tests, according to a study published online June 24 in the Annals of Oncology.
Eric A. Klein, M.D., from the Cleveland Clinic, and colleagues conducted a substudy of the prospective, case-controlled, observational Circulating Cell-free Genome Atlas study to validate the MCED for use as a screening tool. A total of 4,077 participants were included in the independent validation set (2,823 with cancer; 1,254 without cancer).
The researchers reported a 99.5 percent specificity for cancer signal detection. The overall sensitivity was 51.5 percent for cancer signal detection, with increased sensitivity with stage (sensitivity, 16.8, 40.4, 77.0, and 90.1 percent for stage I, II, III, and IV, respectively). In 12 prespecified cancers that account for approximately two-thirds of annual U.S. cancer deaths, stage I to III sensitivity was 67.6 percent; and for all cancers, stage I to III sensitivity was 40.7 percent. Across more than 50 cancer types, cancer signals were detected. In true positives, the overall accuracy of cancer signal origin prediction was 88.7 percent.
"These data add to a growing body of literature that supports the use of next-generation sequencing for the detection of cell-free DNA in blood samples as a tool for earlier detection of common cancers that account for a significant number of deaths and other health problems worldwide," Klein said in a statement. "In addition, a screening test that requires only a simple blood draw could provide an option for communities that have poor access to medical facilities. I'm excited about the potential impact this approach will have on public health."
Several authors disclosed financial ties to biopharmaceutical companies, including GRAIL Inc., which funded the study.