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After Securing CE-IVD for Debut Hereditary Cancer Dx, Korea’s NGeneBio Readies NGS Tests for Launch
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NEW YORK (GenomeWeb) – Fresh from achieving a CE-IVD mark for its flagship next-generation sequencing test for hereditary breast and ovarian cancer, Korean molecular diagnostics startup NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in its home market, while envisioning a 2019 submission to the US Food and Drug Administration.
Moreover, the company is readying a number of new sequencing panels, particularly companion diagnostics for cancer drugs, which NGeneBio considers its primary focus, according to YoungJoon Moon, the firm’s director of business development.