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NEW YORK (Reuters Health) - An improved and simplified version of a first generation stool DNA test shows considerable efficacy in detection of colorectal cancer, according to North American researchers.
"This new version of the stool DNA test," lead investigator Dr. Steven Itzkowitz told Reuters Health, "offers rather high sensitivity for colorectal cancer using a much simpler assay."
"Now that stool DNA testing has been included in the latest colorectal cancer screening recommendations of the American Cancer Society and the leading GI organizations," he added, "it offers a viable option for people who prefer to use a non-invasive, stool-based screening test."
In the November issue of the American Journal of Gastroenterology, Dr. Itzkowitz of Mount Sinai School of Medicine, New York, and colleagues report that the improved test, which employs hypermethylated vimentin gene and a two-site DNA integrity assay as markers, demonstrated a sensitivity of 88% and a specificity of 82% in a phase 1a study.
In the current phase 1b study, the researchers sought to validate these findings in stool samples from an independent set of 42 patients with colorectal cancer and 241 with normal colonoscopies.
Optimal marker cutoff points based on the combined datasets, involving 445 samples, yielded an 83% sensitivity and 82% specificity.
Moreover, say the investigators, "The vast majority of cancers were detected regardless of tumor stage, tumor location, or patient age."
In comparison with the older, more complex stool DNA test, they add, "The use of only two markers will make the test easier to perform, reduce the cost, and facilitate distribution to local laboratories."
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