NGeneBio Receives CE Mark for BRCA Test Panel and Data Analysis Software

NGeneBio Receives CE Mark for BRCA Test Panel and Data Analysis Software Regulatory Roundup: September 2017 Date: SEP.1.2017  // Source: Clinical Laboratory News Topics:  Cancer and Tumors, Genetics and Genomics Disorders, Government and Regulatory NGeneBio, a molecular diagnostics startup based in Seoul, South Korea, received the CE mark for BRCAaccuTest and NGeneAnalySys, two next-generation sequencing (NGS) based products that…

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…

NGeneBio Garners CE-IVD Mark for NGS BRCA Test

NEW YORK (GenomeWeb) – NGeneBio, a Korean molecular diagnostics startup, said today that it has achieved a CE-IVD mark for its BRCAaccuTest and clinical analysis software. Seoul-based NGeneBio said the amplicon-based, targeted next-generation sequencing panel can be used to detect mutations in the BRCA1 and BRCA2 genes associated with predisposition to breast and ovarian cancers.…