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Total brochure

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Total brochure

Product catalog summary
Company Overview
NGeneBio Co., Ltd., founded in October 2015 in Seoul, specializes in precision diagnostics using next-generation sequencing (NGS) for in vitro diagnostics, companion diagnostics, liquid biopsy, and clinical bioinformatics software. The company focuses on advancing precision medicine through innovative diagnostic products and clinical data analysis software.
Certifications and Approvals
NGeneBio holds certifications such as ISO 9001:2008, ISO 13485:2012, and CE-IVD registration for products like BRCAaccuTest™ and NGeneAnalySys™. It has also received MFDS approval and recognition as an innovative medical device company by the Ministry of Health and Welfare.
Product Offerings
The company offers molecular diagnostics products, including BRCAaccuTest™ PLUS, HEMEaccuTest™ DNA, and SOLIDaccuTest™ DNA, designed for analyzing genetic variants associated with cancers using NGS technology.
NGS Workflow
The clinical NGS workflow includes sample preparation, DNA/RNA extraction, NGS library preparation, sequencing, and data analysis using NGeneBio software, which provides clinical significance, drug information, and generates clinical and QC reports.
BRCAaccuTest™ PLUS
This reagent kit analyzes BRCA1 and BRCA2 genes, associated with breast and ovarian cancer, using genomic DNA from blood or FFPE tissue. It is compatible with platforms like Illumina MiSeq and has proven effective through MFDS approval and hospital collaborations.
Performance and Clinical Evaluation
BRCAaccuTest™ PLUS shows high reproducibility and accuracy in detecting CNV mutations. Clinical evaluations with 108 samples demonstrated high diagnostic agreement with previously approved products, enhancing clinician efficiency.
Clinical Evaluation and Diagnostic Agreement
BRCAaccuTest™ PLUS was evaluated with 108 clinical samples, showing over 99% diagnostic consistency with BRCAaccuTest® and Sanger sequencing. A discrepancy in two samples was resolved using NGeneAnalySys™, achieving 100% agreement.
Performance Summary
The test achieved a mean coverage of 200X for germline samples and 1,000X for somatic samples, with high accuracy and target specificity. It demonstrated superior reproducibility compared to competitors.
Competitor Comparison Study
BRCAaccuTest™ PLUS showed superior reproducibility compared to competitors, maintaining consistent results across tests.
HEMEaccuTest™ Product Specification
Certified as CE-IVD, the HEMEaccuTest™ DNA and RNA panels target 108 and 53 genes, respectively, with a turnaround time of 2-3 days, used for diagnosing hematologic malignancies.
Performance Test Summary
HEMEaccuTest™ DNA provides high coverage uniformity and accurate analysis of GC-rich regions, with 100% sensitivity and specificity in repeated tests.
Specifications and Performance
  • HEMEaccuTest™: Offers 100% sensitivity and specificity for detecting mutations in hematological malignancies, covering genes like CEBPA and FLT3.
  • SOLIDaccuTest™: Targets 84 genes for DNA and 29 for RNA, focusing on clinically significant variants, with a turnaround time of 3 to 3.5 days.
Technical Details
  • Target Enrichment: Uses targeted sequencing methods for precise detection of genetic variants.
  • Analysis Solution: NGeneAnalySys™ software provides comprehensive data analysis.
Clinical Relevance
These tests provide accurate diagnoses for various cancers, aligned with global clinical guidelines, proven effective through extensive clinical use.
Key Data and Figures
Performance test results show high accuracy in detecting mutations, with figures illustrating gene fusion and MET exon 14 skipping detection capabilities.
Conclusion
SOLIDaccuTest™ and ONCOaccuPanel™ offer robust solutions for detecting genetic variants in oncology, providing high accuracy and clinical relevance for targeted cancer therapies.
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Catalog excerpts

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Boost Your Engine Dynamic Software for Smart NGS Diagnostics

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NGeneBio 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 development...

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CE-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 development...

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Table of Contents Cancer BRCA test Hematologic malignancies Solid tumors Comprehensive oncology Data analysis Infectious disease Tuberculosis Respiratory disease Automated System Nucleic acid extraction

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Clinical 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 analysis...

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Verified 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 genes...

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coverage 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 product...

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Verified 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 hematologic....

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HEMEaccuTest™ 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™) Category...

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Verified 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 isolatedgastricwhole...

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SOLIDaccuTest™ 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 : Index...

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Verified 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 capable...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.