Catalog excerpts
Boost Your Engine Dynamic Software for Smart NGS Diagnostics
Open the catalog to page 1NGeneBio provides molecular diagnostics products and services to convey values to the Molecular Diagnostics (Next-Generation Sequencing(NGS)/PCR healthcare community based on competencies in clinical bioinformatics and expertise for precision diagnostics. Our mission is to provide clinically validated NGS-based IVD/CDx products/services with the convergence of innovative bioinformatics and Companion Diagnostics We would like to contribute to a new era of precision NGeneBio Co., Ltd. Established: Oct 2015 in Seoul, Republic of Korea Business field: Precision diagnostics products/services...
Open the catalog to page 2CE-IVD registration: HEMEaccuTest™ DNA, BRCAaccuTest™ PLUS Exhibition & Sponsor: MEDICA, AACC, MEDLAB, FIME, KSGD, KSLM CE-IVD registration: HLAaccuTest™ All, NGenePlex™ nCoV/FluA.B Detection Kit, ONCOaccuPanel™, Supplied precision diagnostics products to 15 large hospitals including SNUH and AMC MFDS approval: BRCAaccuTest™ PLUS, HLAaccuTest™ PARPi targeted therapy companion diagnostics study with Samsung Medical Center and P global pharma Distributorship agreement: 24 partners Won the grand prize for pitching in K-STARTUP Mentoring program (KITA) in Jakarta, Indonesia Agreement for CDx...
Open the catalog to page 3Table of Contents Cancer BRCA test Hematologic malignancies Solid tumors Comprehensive oncology Data analysis Infectious disease Tuberculosis Respiratory disease Automated System Nucleic acid extraction
Open the catalog to page 4Clinical NGS Workflow Clinical NGS Workflow Sample (Blood/FFPE) DNA/RNA extraction Target nalysis S/W enrichment eneAnalySys™ Products Target nalysis S/W enrichment eneAnalySys™ Products Working Process Sample (Blood/FFPE) Amplicon-based Panel DNA/RNA extraction BRCAaccuTest™ PLUS Amplicon-based Panel BRCAaccuTest™ PLUS NGeneBio NGS Panel NGS library preparation NGeneBio Report Clinical report generation NGeneBio Software NGS data analysis NGS Sequencer NGS data generation for target genes Analysis S/W Products Products NGeneBio Report NGeneBio Software Clinical report generation NGS data...
Open the catalog to page 6Verified genetic variants analysis for BRCA test The mutation of BRCA1 and BRCA2, which are tumor suppressor genes, can cause breast and ovarian The mutation of BRCA1 and BRCA2, which are tumor suppressor genes, can cause breast and ovarian cancer. The cause of mutation is classified as germline or non-germline. BRCAaccuTest™ PLUS is cancer. The cause of mutation is classified as germline or non-germline. BRCAaccuTest™ PLUS is a reagents kit for producing libraries to analyze the BRCA1 and BRCA2 genes using genomic DNA a reagents kit for producing libraries to analyze the BRCA1 and BRCA2...
Open the catalog to page 7coverage Uniformity (MiSeq Reagent Nano kit v2, 300cycles / 24 tests) (MiSeq Reagent Nano kit v2, 300cycles / 6 tests) 100% detected >2.0 mean coverage BRCAaccuTest™ PLUS Clinical Evaluation Negative BRCAaccuTest™ PLUS enables clinicians to be more Total The clinical performance evaluation of BRCAaccuTest™ PLUS was conducted with 108 clinical samples efficient and effective enables clinicians to be more including 54 positives in BRCA1 Clinical Evaluation and 54 positives in BRCA2, which was previously confirmed by a BRCAaccuTest™ PLUS enables clinicians to be more Clinical Evaluation...
Open the catalog to page 8Verified genetic variants screening for hematologic malignancies NGeneBio provides the precision diagnostic kit of HEMEaccuTest™ for the hematologic malignancies including AML, ALL, Lymphoma, MM, MSDS/MPN. The target genes on the panels have been selected based on clinical significance, considered global guidelines, and clinical databases, each 108 for DNA The mutation of BRCA1 addition, this panel helps clinicians focus genes, can cause breast and to and 53 for RNA panel. Inand BRCA2, which are tumor suppressor on clinically important variantsovarian cancer. accurate diagnosis of...
Open the catalog to page 9HEMEaccuTest™ proved its competitiveness through analytical performance tests Performance Test : Summary) Test ( Summary Distribution of CEBPA mutations in hematop oietic malignancies - Specificity = TN/(TN+FP) = 100% in average of three repeats carrying target mutations. Also comparing the mutation detection (100, 100, 100%) rate of the clinical samples carrying certain mutations previously ⦁ analyzed. using the DNA samplesthe minimum mutation allele ⦁ Sensitivity: using SNV 2% SNV 1% Performance Test (Summary) Limit of detection (LOD) INDEL 2% 3% NGS (HEMEaccuPanel™) NGS (HEMEaccuTest™)...
Open the catalog to page 10Verified genetic variants analysis for BRCA test Verified genetic variants screening for solid tumor The mutation of BRCA1 and BRCA2, which are tumor suppressor genes, can cause breast and ovarian cancer. The cause of mutation is classified as germline or non-germline. BRCAaccuTest™ PLUS is NGeneBio kit for producing libraries to analyze the BRCA1 and for solid tumors including lung a reagentsprovides the precision diagnostic kit of SOLIDaccuTest™BRCA2 genes using genomic DNA cancer, from cancer, colon cancer, breast/ovarian next-generation sequencing The target genes on...
Open the catalog to page 11SOLIDaccuTest™ is optimized for development as a CDx. SOLIDaccuTest™ with analysis software SOLIDaccuTest™ is composed of clinically significant genes in targeted cancer therapy. Furthermore, ‘NGeneAnalySys™’ analyzes data for you by simplifying the process SOLIDaccuTest™ is optimized for development as a CDx. SOLIDaccuTest™ with analysis software ‘NGeneAnalySys™’ analyzes data for you by simplifying the process Detection of variants ariants detection D : Mutation detection, MND : Mutation non-detection Detection of variants Performance be more SOLIDaccuTest™ enables clinicians to Test :...
Open the catalog to page 12Verified genetic variants analysis for BRCA test Verified genetic variants screening for The mutation of BRCA1 and BRCA2, which are tumor suppressor genes, can cause breast andVerified ge ovarian Verified genetic variantsas germline or non-germline. BRCAaccuTest™ PLUS is Verified genetic oncology variants screening Verified geneticmutation is classified screening for cancer. The cause of variants screening for for comprehe comprehensive a reagents kit for producing libraries to analyze the BRCA1 and BRCA2 genes using genomic DNA comprehensiveor FFPE tissue with analysis for that can be...
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