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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.