QuickView: Epi proColon gets FDA fillip
In a surprise move, the FDA has reversed its request for a new behavioural study of Epigenomics’ blood-based colorectal cancer (CRC) diagnostic test, Epi proColon. US marketing clearance and launch now look likely over the coming few months. With a current cash reach to H216, a cash call may now be deferred until after a possible US approval, and the consequent increased certainty may prove beneficial to current shareholders.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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