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Exact Sciences Files Second Module of PMA Application with FDA

NEW YORK (GenomeWeb News) – Exact Sciences today said that it has filed the second module of a premarket approval application for its Cologuard colorectal cancer screening test with the US Food and Drug Administration.

The module, which was submitted to the agency on Friday, was comprised of the required studies and documentation establishing the analytical sensitivity and specificity, cross-reactivity, and other similar studies on the test. The firm said that the third and final module will include clinical data from its DeeP-C trial.

Madison, Wis.-based Exact Sciences previously said that it expects to report top-line results from the DeeP-C pivotal trial in March 2013.

The firm filed the first module of the PMA with the FDA in December. That module contained information on manufacturing and quality control systems for Cologuard, a stool-based DNA test.