Exact Sciences falls on Cologuard data
Exact Sciences Corp. (NASDAQ:EXAS) fell $1.13 (11%) to $8.84 Thursday after its colorectal cancer test met the endpoints in a pivotal trial but may have fallen short of investors' expectations. Cologuard had 92% sensitivity and 87% specificity for detecting colorectal cancer. The test also met the secondary endpoint of detecting precancerous polyps, with 42% sensitivity for detecting precancerous polyps and 66% sensitivity for detecting precancerous polyps 2 cm or greater. However, analysts were expecting Cologuard to have a detection rate of 55-65% for precancerous polyps, based on previous trials of the diagnostic. The pivotal trial enrolled over 10,000 patients at risk of developing colorectal cancer.
Exact Sciences plans to submit the clinical and final module of a PMA to FDA for the assay in May or June. Cologuard is a non-invasive stool DNA test that utilizes a multiplexed quantitative Invader assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene. ...