Epigenomics - PMA filing on back of non-inferiority
Jan 02nd 2013 - Edison Investment Research today published a report on Epigenomics entitled "PMA Filing On Back Of Non-inferiority". In summary, the report says:
Epigenomics expects to complete its PMA submission for Epi proColon, following the completion of its head-to-head study with faecal immunochemical testing (FIT) in the detection of colorectal cancer (CRC). The study, which forms an integral part of the final module of the PMA submission, met its key end point of non-inferiority with respect to sensitivity. Thus, the key question for investors now is whether Epi proColon can find a place in the rapidly evolving commercial landscape for CRC screening and how successfully Epigenomics can compete with larger players.
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