DiaCarta's ColoScape assay effectively detects precancerous colorectal cancer lesions and colorectal cancer, according to a study recently published in PLOS One.
DiaCarta's ColoScape xenonucleic acid (XNA)-mediated quantitative real-time polymerase chain reaction clamping assay targets 19 mutations in a panel of genes linked with early precancerous colorectal cancer lesions. ColoScape detects mutant cell-free DNA (cfDNA) mutations with high sensitivity, according to the results.
ColoScape uses XNA technology and synthetic xenonucleic acid molecular oligomers that hybridize with target wild-type DNA sequences. The XNA oligomers act as molecular clamps to enable the accurate amplification of mutant sequences only.
For this study, the assay analyzed 380 clinical samples, including plasma cfDNA and formalin-fixed paraffin-embedded (FFPE) samples from patients with precancerous and different stages of colorectal cancer.
When liquid biopsy samples were used, the assay's clinical specificity for colorectal cancer was 100%, and the clinical sensitivity was about 92%. For precancerous lesions, clinical specificity was 95%, and clinical sensitivity was about 63%, according to the results.
When the FFPE tissue samples were used, the assay's clinical specificity for cancer was 96%, and the clinical sensitivity was 92%, according to the study.
Currently, DiaCarta has large clinical trials ongoing in Europe, Asia, and the U.S.