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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. The test is performed using Illumina instruments and is run in combination with NGeneBio's NGeneAnalySis software.

CEO Daechul Choi said in a statement that NGeneBio is planning to launch the new offering in Europe, as well as China and other Southeast Asian countries "with competencies in clinical validated quality and reliability." Choi said that the firm aims to have it cleared as an in vitro diagnostic by the Korean Ministry of Food and Drug Safety later this year. The test became available for research use last year.

NGeneBio was established in 2015 as a joint venture between Gencurix, a Seoul-based molecular diagnostics company that has developed a PCR-based breast cancer test, and Korea Telecom. NGeneBio said it is currently developing other assays for solid and hematological cancers, including a companion diagnostic for patients undergoing treatment with PARP inhibitors. The company hopes to launch these tests by year end.