FDA committee sets dates for colorectal cancer tests
The Molecular and Clinical Genetics Panel of FDA's Medical Devices Advisory Committee will meet March 26-27 to discuss two colorectal cancer tests. The panel will meet on March 26 to discuss a PMA for Epi proColon 2.0 from Epigenomics AG (Xetra:ECX). Epi proColon 2.0 is a second-generation test that uses real-time PCR to detect methylated DNA of the Septin 9 gene in blood plasma. Epigenomics markets a first-generation version in Europe.
The panel will meet on March 27 to discuss a PMA for Cologuard from Exact Sciences Corp. (NASDAQ:EXAS). Cologuard is a non-invasive stool DNA test that uses a multiplexed quantitative assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene. ...