QuickView: Epi proColon – impending FDA decision
The conclusion of the behavioural study (ADMIT) may pave the way for US regulatory approval and launch of Epigenomics’ novel Epi proColon bloodbased colorectal cancer (CRC) test in Q415. While ADMIT proved superior compliance using Epi proColon, the abnormally high compliance rate inthe control group may prolong the approval process. Eventual progress towards US approval may however, support a share price recovery.
Epigenomics is a holding company. Through its Epigenomics Inc. subsidiary, Co. is engaged as a molecular diagnostics company focusing on developing and commercializing of in vitro diagnostic (IVD) tests for the screening and diagnosis of cancer. Co.'s products are based on a proprietary technology platform, which utilizes a biological phenomenon called DNA methylation as a source for the discovery of disease-specific biomarkers. Co. develops and commercializes cancer diagnostic tests in colorectal cancer (CRC) and in lung cancer. Co.'s key product is Epi proColon®, a blood-based test for the early detection of CRC which utilizes its proprietary DNA methylation biomarker, Septin9.
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