Rhythm Biosciences Ltd. announced the statistical analysis outcomes of its clinical trial (Study 7) as verified by Rhythm's third-party statisticians, for ColoSTAT®, its simple blood test for the detection of colorectal cancer, aimed at global mass market screening. The clinical confirmed ColoSTAT® exhibited very high accuracy for the detection of colorectal cancer, recording a sensitivity1 of 81% and a specificity2 of 91%. Previous ASX announcements of testing outcomes demonstrated ColoSTAT® to be 33% more accurate than the current market standard Faecal Immunochemical Test (FIT). Pleasingly, the clinical trial (Study 7) has not only confirmed this performance but in fact increased to demonstrate that ColoSTAT® is 35% more accurate than the globally adopted FIT for detecting colorectal cancer. Further, the trial also showed ColoSTAT® to be more accurate than FIT at detecting advanced adenomas.
ColoSTAT® was not directly related to any adverse events recorded, all of which were classified as minor.