Regulatory Roundup: September 2017
Date: SEP.1.2017 // Source: Clinical Laboratory News
· 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 test for hereditary breast and ovarian cancer. BRCAaccuTest is an amplicon-based NGS panel that identifies and analyzes mutations in the BRCA1 and BRCA2 genes. It takes 2 days to complete and is intended to identify patients who may have a genetic predisposition to breast or ovarian cancer. NGeneAnalySys is an NGS clinical analysis software package that is registered for combined use with BRCAaccuTest. It draws from more than 20 genetic information databases and provides quality control and clinical report generation.
NGeneBio is the first Asian company to obtain CE marking for the clinical use of an NGS panel and analysis software for BRCA testing. The company is also currently conducting clinical validation for approval from the Korean Ministry of Food and Drug Safety for the combined use of both products.
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