QuickView: New FDA demands delay US launch further
Epigenomics announced another delay to the US launch of its blood-based CRC diagnostic test Epi proColon and a moderate downgrade to its FY15 guidance. The FDA demands more evidence of increased compliance in CRC screening using Epi proColon, which is likely to necessitate a further study. With a current cash reach to H216, a cash call is likely before a possible US approval.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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