After Securing CE-IVD for Debut Hereditary Cancer Dx, Korea’s NGeneBio Readies NGS Tests for Launch

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…

Korean IVD startup NGeneBio receives CE-IVD mark for next generation sequencing-based BRCA 1/2 test panel and clinical analysis software

SEOUL, South Korea, July 6, 2017 /PRNewswire/ — Molecular diagnostics startup NGeneBio Co., Ltd. of Korea has received CE-marking for next generation sequencing (NGS)-based in vitro diagnostics (IVD) products, BRCAaccuTestTM and clinical analysis software, NGeneAnalySysTM for hereditary breast/ovarian cancer genetic testing (30/Jun). BRCAaccuTestTM is an amplicon-based targeted NGS panel which detects germline mutations in BRCA1…