NGeneBio was founded in 2015 as a spin-off venture from Korea Telecom (KT), develops in vitro diagnostics (IVD)/companion diagnostics (CDx) products and bioinformatics Software with cutting-of-edge technologies including next generation sequencing (NGS). The company launched NGS-based breast/ovarian cancer panel (BRCAaccuTest™) with clinical analysis SW (NGeneAnalySys™) and received CE-IVD and KFDA approval in 2017. Additionally, The Company launched NGS panels and SW for solid tumor (SOLIDaccuTest™) and hematological malignancies (HEMEaccuTest™, CE-IVD marked in 2018). Apart from NGS panels & SW, NGeneBio has also launched the DNA profiling kit, IDaccuTest™, which is based on short tandem repeat (STR) analysis and using capillary-electrophoresis technology which can be used for human DNA profiling and chimerism monitoring after a blood transfusion or bone marrow/stem cell transplantation. In 2020, NGeneBio is releasing new NGS panels of HLAaccuTest™ & ONCOaccuPanel™. HLAaccuTest™ is an in vitro diagnostic medical device for HLA (human leukocyte antigen) typing that can identify high-resolution histocompatibility antigens with analysis software EasyHLAanalyzer™. ONCOaccuPanel™ is a comprehensive cancer panel capable of identifying various genetic mutations and immunotherapy biomarkers (TMB, MSI) in solid tumors with analysis software NGeneAnalySys™.
ONCOaccuPanel™ is a comprehensive cancer panel capable of identifying immunotherapy biomarkers TMB (tumor mutational burden) and MSI (Microsatellite Instability) using next-generation sequencing (NGS). This panel targets the 323 genes (225 genes with entire coding exon, 98 genes with partial exon/hot spots) associated with solid tumors. The NGS data produced with ONCOaccuPanel™ can be analyzed with the automated analysis software NGeneAnalySys™, which enables identification of all DNA variants (SNVs, INDELs, CNV, SV, translocation).