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A previous multicenter U.S. trial showed that fecal DNA testing (for 22 mutations plus DNA integrity) had a sensitivity of 52% and a specificity of 94% for colorectal cancer detection (Journal Watch Gastroenterology Jan 19 2005). Its sensitivity was superior to that of nonrehydrated guaiac-based fecal occult blood testing (Hemoccult II sensitivity, 13%). However, the DNA integrity assay (DIA), which was considered to be the single most sensitive component of the fecal DNA test, was noninformative because of DNA instability in the samples.
In an ongoing effort to improve the fecal DNA test sensitivity, the manufacturer supported a multicenter investigation of new test components — the previous mutation analysis, DIA with a new protocol (addin…