ARTICLE | Clinical News

Stool DNA colorectal cancer screening assay: Pilot trial data

August 2, 2010 7:00 AM UTC

A pilot trial evaluating tissue samples from 22 colorectal cancers, 10 pre-malignant advanced adenomas and 12 normal control epithelia showed that Exact's stool DNA colorectal cancer screening assay had 100% sensitivity and 100% specificity for detecting colorectal cancer and pre-cancer. Additionally, the assay was able to detect <10 copies of methylated or unmethylated VIM a known colorectal cancer marker. The assay also detected methylated VIM spiked in unmethylated VIM at a 0.01% ratio and vice versa. Data were presented at the American Association of Clinical Chemistry meeting in Anaheim.

Exact plans to report data from a validation study evaluating the assay in about 1,650 stool samples at the American Association for Cancer Research meeting in Philadelphia in October. Last year, Exact received exclusive, worldwide rights from Hologic Inc. (NASDAQ: ...