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NGeneBio Co., Ltd. was founded in October 2015, develops next generationsequencing (NGS)-based in vitro diagnostics (IVD)/companion diagnostics (CDx)products and clinical bioinformatics software (SW). The company launched NGS-based hereditary breast/ovarian cancer panel(BRCAaccuTestTM) with clinical analysis SW (NGeneAnalySysTM)and received CE-IVD mark in Jun/2017, followed by Ministry of Food and DrugSafety(MFDS) approval in Dec/2017 based on clinical trial with over 200 BRCAclinical samples.NGSpanels hematologic malignancies (HEMEaccuTest) have been launched, inclusive ofclinical data analysis and report generation SW platform. In support of LaboratoryMedicine, our mission is to provide clinically validatedNGS-IVD/CDx products/services with the convergence of innovative biotechnologyand bioinformatics.
Hematologic malignancy refers to malignant tumors that occur in blood, blood vessels, lymph nodes, lymphatic organs, and constitute a variety of gene instability such as gene mutation, rearrangement, and amplification. While existing gene analysis technology only confirms the presence of certain mutations in cancer genes, diagnosis using NGS technology makes it possible to analyze the major gene mutation patterns of patients to enable personalized treatment. HEMEaccuTestTM is a product for detecting and analyzing mutations in blood cancer-related genes using NGS.