CellMax Life released results from its U.S. study of the FirstSight blood test that revealed the test detected colorectal cancer with 100 percent sensitivity at 90 percent specificity.
Researchers conducted a single-center, blinded study of 354 patients with no prior CRC diagnosis. The test analyzed three biomarkers: circulating gastrointestinal epithelial cells, somatic mutations and methylation of cell-free DNA.
The test also detected advanced adenomas with 76 percent sensitivity at 90 percent specificity. Researchers said the test can achieve higher specificity rates if patients with prior history of advanced adenomas were removed from the pool.
Researchers concluded: "A novel noninvasive blood-based assay that analyzes cell-free DNA and circulating gastrointestinal epithelial cells and integrates age and gender can detect colorectal adenomas and cancer. Compared with existing stool tests, the CMx multimodal blood test significantly improves the sensitivity for advanced and non-advanced adenomas with high specificity."
CellMax is designing a multicenter, prospective clinical study to further validate the results.