QuickView: Epi proColon gets the FDA’s nod
Epigenomics has announced that the US FDA has approved Epi proColon, the company’s blood-based colorectal cancer (CRC) test. The product, which has become the first FDA-approved test of its kind, will be marketed in the US in co-operation with Polymedco, the largest distributor of CRC screening tests. With launch expected imminently, the US approval opens up a potential commercial opportunity of $2bn. However, we expect that additional investment in commercialisation activities will be needed.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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