Biotech Values

[DewDiligence]

Re: EXAS DeeP-C results

Preliminary, top-line data show that Cologuard demonstrated 92 percent sensitivity for the detection of colorectal cancer and 42 percent sensitivity for the detection of pre-cancerous polyps, including 66 percent sensitivity for polyps equal to or greater than 2 centimeters. The test achieved a specificity of 87 percent during the trial.

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.