FDA clears Enterix' colorectal cancer FOBT (faecal occult blood test):
This article was originally published in Clinica
Executive Summary
Enterix has received US FDA 510(k) clearance for its !nSure faecal occult blood test (FOBT) for screening colorectal cancer. The immunochemical test addresses patient compliance-limiting deficiencies associated with existing FOBTs, says the company, which has headquarters in Falmouth, Maine, and in Sydney, Australia. Unlike other FOBTs, Enterix claims its test does not have dietary or medicinal restrictions, it is specific for lower intestinal bleeding and requires only two days of samples instead of three.