Although these data meet the requirements in the SPA, they fall short of investors’ and the companies’ expectations from the phase-2 data. In particular, the specificity of only 87% is problematic for a test intended for the general (i.e. low-risk) population; it will lead to a large number of false positives for each true positive.
The sensitivity for pre-cancer of 42% is also disappointing insofar as finding polyps before they turn cancerous is one of the main goals of this kind of screening.
Al told, the DeeP-C data may be good enough for FDA approval, but commercial success is less certain.