Exact Sciences on Path to Filing PMA for Cologuard in 2012 | GenomeWeb

Exact Sciences will enroll patients at 60 sites in the US and in Canada to conduct the pivotal trial for its Cologuard multi-analyte molecular screening test for colorectal cancer.

Data from the trial, which began enrolling patients on June 30, will be submitted to the US Food and Drug Administration to support Exact Sciences' premarket approval application for the test, analyzes stool DNA for methylation markers and mutation markers associated with colorectal cancer.

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