Sensitivity for Cancer Stages 1-4:
35%, 63%, 46%, and 77.4% respectively.
Sample Size: 7,941 men (45%) and women (55%), mean age 60 years.
From the "Gut" publication:
"Our study using the blood based mSEPT9 test showed that CRC signal in blood can be detected in asymptomatic average risk individuals undergoing screening. However, the utility of the test for population screening for CRC will require improved sensitivity for detection of early cancers and advanced adenomas.
We believe that tests must show at least 50% sensitivity to meet guidelines published by the ACS and the Multi-Society Task Force on Colorectal Cancer."
In spite of all that, Epi has submitted an application to the FDA. I believe the numbers you quote are inferior to FIT. I assume that Epi staff is bright enough to #$%$ whether they can clear the bar, ie. show non-inferiority to FIT.