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Korean MFDS Clears NGeneBio's Breast and Ovarian Cancer Test

NEW YORK (GenomeWeb) – The Korean Ministry of Food and Drug Safety has cleared NGeneBio's BRCAaccuTest for clinical use. The Seoul-based company said this week that its next-generation sequencing panel has been approved as an IVD, the first NGS test to be cleared in Korea.

The BRCAaccuTest is an amplicon-based targeted sequencing panel for mutations in the BRCA1 and BRCA2 genes that are associated with an increased risk of developing breast and ovarian cancers. NGeneBio launched the assay in 2016 and gained a CE-IVD mark for it last year.

YoungJoon Moon, the firm's director of business development, said that NGeneBio carried out a clinical validation study with Seoul National University Hospital to achieve MFDS approval. Specifically, 206 samples with BRCA1 and BRCA2 pathogenic variants that had been previously tested with Sanger sequencing were retested on the BRCAaccuTest platform and the results were compared. Moon said there was complete concordance between the assays.

NGeneBio also offers NGeneAnalySys, a sequencing data analysis platform for generating clinical reports. BRCAaccuTest can be run using various Illumina sequencing instruments, including the MiSeq, MiSeqDx, NextSeq, and HiSeq, according to the firm.