What NGeneBio does

NGeneBio (KOSDAQ: 354200) is a publicly listed South Korean precision diagnostics company that develops and commercializes next-generation sequencing (NGS)-based in vitro diagnostic (IVD) panels, bioinformatics analysis software, and hospital-integrated genomic information systems. The company serves large university hospitals, clinical laboratories, pharmaceutical companies, and—through its 'na-e' mobile application—general consumers in South Korea and across 28 international markets including Vietnam (where it holds #1 market share as of February 2025), Saudi Arabia, UAE, and the United States, where it operates two CLIA-certified laboratories acquired in 2024. Leadership is headed by CEO Kim Min-sik, with a newly appointed Chief Data Officer (Jenny Song, Ph.D., ex-Spark Therapeutics) driving a genomic data licensing business launched in 2025.

Its product portfolio spans oncology precision panels (BRCAaccuTest, HEMEaccuTest, ONCOaccuPanel covering 344+ genes, SOLIDaccuTest, MRDaccuPanel AML FLT3), infection diagnostics (MTBaccuPanel for tuberculosis, NGenePlex nCoV/FluA.B), HLA tissue-typing kits (HLAaccuTest), and software including NGeneAnalySys (NGAS) with 20+ integrated databases, EasyHLAanalyzer, and the AI-powered NPAS pathology analysis tool. The company holds multiple MFDS and CE-IVD certifications, including several first-in-Korea and first-in-Asia approvals dating back to 2017. The NGLIS system integrates hospital EMR with genomic workflows and was deployed at Seoul Asan Hospital in November 2024; the G-Hub platform consolidates multimodal clinical, genomic, and pathology data for AI-driven decision support and real-world evidence research. NGeneBio's AI capabilities are anchored by a January 2026 license to LG AI Research's EXAONE Path 2.0 EGFR prediction model.

NGeneBio monetizes through one-time IVD kit and reagent sales, software licenses, recurring NGLIS system maintenance, DTC genetic testing subscriptions, and—since September 2025—a pharmaceutical distribution business acquired through subsidiary EngenPharma (formerly Nuripharma). Consolidated 2025 revenue reached 21.24 billion KRW with 278.5% year-over-year growth, though this is materially inflated by the EngenPharma consolidation; standalone diagnostic-segment revenue grew approximately 36% year-over-year in Q1 2026. The company remains unprofitable (8.3 billion KRW operating loss in 2025) and announced a ~224 billion KRW rights offering in June 2026 to fund AI platform development, NGLIS expansion, and debt reduction.

Name

NGeneBio

Legal name

주식회사 엔젠바이오

Website

https://ngenebio.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

51–100 employees

Short description

NGeneBio is a KOSDAQ-listed South Korean precision diagnostics company developing NGS-based IVD panels, bioinformatics software, and hospital genomic information systems for hospitals, laboratories, pharmaceutical companies, and consumers across 28 countries.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (6215), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Medical Laboratories (621511)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Genomics & Next-Generation Sequencing (NGS) Services (HLAGANAA)

akta.pro secondary industries

Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE), Genomic & Multi-Omic Biomarkers (NGS panels, transcriptomics, proteomics, metabolomics) (HLAAAMAJ)

Keywords

• NGS diagnostic panels
• Precision oncology diagnostics
• Clinical bioinformatics software
• Companion diagnostic tests
• Liquid biopsy diagnostics

Headquarters

HQ city

Gurugram

HQ country

India

HQ region

Asia

Offices6 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. Precision Diagnostic Products (NGS Panels): Sale of IVD-certified NGS-based precision diagnostic panels including BRCAaccuTest, HEMEaccuTest, ONCOaccuPanel, SOLIDaccuTest, HLAaccuTest, and infection diagnosis kits to hospitals and clinical laboratories domestically and internationally. Revenue from product kit sales and reagent supply.
2. Analysis Software (NGeneAnalySys, EasyHLAanalyzer): Sale and supply of bioinformatics analysis software for precision diagnostic panels, providing variant detection, interpretation, and clinical reporting. Software provided as local server-based solution to hospitals and laboratories.
3. NGLIS Hospital Integrated Information System: Construction and supply of NGLIS integrated genomic information management systems to major university hospitals in Korea, creating system build revenue and ongoing software maintenance/support revenue.
4. DTC Genetic Testing Services: Direct-to-Consumer genetic testing services to general consumers through the 'na-e' mobile app, providing personalized health management solutions based on genetic analysis and microbiome testing.
5. Pharmaceutical Distribution (via subsidiary NGenePharma): Specialty pharmaceutical distribution business through subsidiary NGenePharma (merged with Nuripharm in 2025), providing stable cash-cow revenue. NGenePharma contributed approximately 10.36 billion KRW in quarterly revenue (Q1 2026) and 103.6 billion KRW in annual sales in 2025.
6. Genome Data Licensing and AI Services: Plans to license Korean/Asian genomic datasets to global pharmaceutical and biotech companies for drug discovery and precision medicine research, with newly appointed CDO Jenny Song (Ph.D.) leading data business expansion. Participation in Bio USA 2026 for global genomic data partnership discussions.

Go-to-market motion3 records

Distribution channels6 records

Marketing channels8 records

Core offering

NGeneBio develops, manufactures, and commercializes IVD-certified NGS-based precision diagnostic panels and reagent kits for cancer (solid tumor and hematological malignancies), tissue compatibility (HLA), and infectious diseases, along with bioinformatics analysis software (NGeneAnalySys, EasyHLAanalyzer, NPAS) and integrated hospital genomic information management systems (NGLIS, G-Hub). The company supplies these products and platforms to hospitals, clinical laboratories, and pharmaceutical companies globally, while also operating US CLIA labs and a direct-to-consumer genetic testing mobile service.

Product overview

NGeneBio is a multi-product precision medicine platform company offering an integrated portfolio of NGS-based diagnostic kits, bioinformatics analysis software, and hospital-integrated data management systems. The portfolio consists of: (1) precision diagnostic panels (BRCAaccuTest, HEMEaccuTest, ONCOaccuPanel, SOLIDaccuTest, HLAaccuTest, MRDaccuPanel AML FLT3) for hereditary cancer, solid tumor, hematological malignancy, and tissue compatibility testing; (2) infection diagnostic products (NGenePlex nCoV/FluA.B Detection Kit, MTBaccuPanel); (3) analysis software platforms (NGeneAnalySys/NGAS for variant detection/interpretation, EasyHLAanalyzer for HLA genotyping, NPAS for AI pathology image analysis); and (4) integrated hospital information systems (NGLIS for genomic laboratory workflow management, G-Hub for multimodal AI precision medicine data platform). Products are regulated medical devices with MFDS and/or CE-IVD certifications. The platform integrates with hospital EMR systems and connects to Illumina sequencing instruments.

Differentiator

Problem solved

Functional benefit

Brands

• BRCAaccuTest / BRCAaccuTest PLUS: NGS-based precision diagnostic panel for hereditary breast and ovarian cancer (BRCA1/2 genes). First Korea MFDS and first-in-Asia CE-IVD approved.
• HEMEaccuTest
• ONCOaccuPanel
• SOLIDaccuTest
• HLAaccuTest / HLAaccuTest All
• NGenePlex
• MTBaccuPanel
• NGeneAnalySys (NGAS)
• EasyHLAanalyzer
• NGLIS
• G-Hub Platform
• NPAS (NPathAnalySys)
• MRDaccuPanel
• na-e (나에)
• WELFIT
• NGeneBio

Products and services

• BRCAaccuTest / BRCAaccuTest PLUS NGS-based precision diagnostic panel for detecting BRCA1 and BRCA2 gene variants (SNV, INDEL, CNV) in hereditary breast and ovarian cancer patients. The PLUS version adds expanded target regions for CNV detection and improved data uniformity. MFDS and CE-IVD certified. First Korea MFDS and first-in-Asia CE-IVD approved product.
• HEMEaccuTest DNA / RNA NGS-based precision diagnostic panel detecting approximately 100 gene variants associated with hematological malignancies including AML, ALL, MDS/MPN, MM, and lymphoma. DNA panel targets SNV/INDEL; RNA panel targets structural variants (fusions). CE-IVD certified.
• ONCOaccuPanel Large-panel pan-cancer NGS diagnostic product analyzing 344 genes from solid tumor FFPE/tissue specimens, detecting SNV, INDEL, CNV, SV (Fusion), TMB, and MSI for 35+ solid cancer types. Technology transferred from Seoul Asan Hospital and Harvard Dana-Farber Cancer Institute. CE-IVD certified.
• SOLIDaccuTest DNA / RNA / HRD NGS-based solid cancer precision diagnostic panel targeting approximately 100 genes (84 genes DNA, 29 genes RNA, 111 genes HRD) for detecting mutations (SNV, INDEL, CNV) and NTRK gene fusions in lung, colorectal, gastric, and breast cancers. MFDS and CE-IVD certified.
• HLAaccuTest / HLAaccuTest All NGS-based tissue compatibility (HLA) genotyping test for donor-recipient matching in organ and bone marrow transplantation, identifying HLA-A, B, C, DRB1, DQB1, DRB3/4/5, DQA1, DPA1, DPB1 alleles at high resolution. MFDS and CE-IVD certified.
• MRDaccuPanel AML FLT3 NGS-based minimal residual disease (MRD) diagnostic panel for acute myeloid leukemia (AML), detecting FLT3 gene ITD and TKD variants at 0.001% VAF sensitivity. Achieves MRD detection rate improvement from ~8% to ~53% (6x improvement) compared to fragment analysis per ELN guidelines. MFDS export manufacturing approval obtained.
• NGenePlex nCoV qRT-PCR Kit Real-time RT-PCR diagnostic kit for qualitative detection of SARS-CoV-2 (COVID-19) nucleic acid from respiratory specimens. CE-IVD and MFDS export approval certified.
• NGenePlex nCoV/FluA.B Detection Kit Real-time RT-PCR-based in vitro diagnostic kit for simultaneous qualitative detection of SARS-CoV-2, Influenza A, and Influenza B from respiratory specimens. CE-IVD and MFDS export approval certified.
• MTBaccuPanel NGS-based diagnostic kit for simultaneous identification of mycobacteria and detection of tuberculosis drug-resistance mutations. Developed for respiratory infectious disease diagnostics and pandemic preparedness.
• NGeneAnalySys (NGAS) Local server-based bioinformatics analysis software for precision diagnostic panels that performs automated variant detection, annotation, and clinical interpretation using 20+ validated databases and ACMG/AMP guidelines, providing one-stop NGS data analysis, variant reporting, and QC report generation.
• EasyHLAanalyzer HLA genotyping analysis software that applies bioinformatics algorithms based on IMGT/HLA database to perform NGS data-based HLA typing, supporting genotype results review, coverage/VAF confirmation, and clinical reporting for organ and bone marrow transplantation compatibility testing.
• NGLIS (Next-Generation Genomic Laboratory Information System) Hospital-integrated genomic laboratory information system that connects EMR and genomic analysis software into a single platform, automating genomic testing workflows from order to data analysis, quality management, and clinical reporting using SOP-based standardization.
• G-Hub Platform Next-generation precision medicine platform integrating multimodal data including genomics (NGS), clinical records (EMR), and pathology, standardized to international formats for AI-ready datasets, powering biomarker-based clinical matching, RWE research analytics, and AI decision support.
• NPAS (NPathAnalySys) AI pathology analysis software that processes histopathological tissue images to predict gene mutation probability, using deep learning models including the licensed EXAONE Path 2.0 EGFR variant prediction model, enabling AI + NGS hybrid cancer diagnosis workflows.
• na-e Health Management App Direct-to-consumer mobile health management application providing personalized health services including dietary, lifestyle habit, and microbiome analysis, integrated with personal genetic testing and health coaching. Offers 70 certified DTC genetic testing items approved by the Ministry of Health and Welfare.

Quantifiable outcome

• MRD detection rate improvement from ~8% to ~53% (6x improvement) using MRDaccuPanel AML FLT3 compared to fragment analysis, achieving VAF 0.001% sensitivity per ELN guidelines.
• +4 more outcomes

Named customers8 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability6 records

Feature7 records

Partnerships

20 partnerships are on record, tiered core and minor.

• Catholic University Yeouido St. Mary's HospitalcoreStrategic or Co-development Partner · 19 June 2026Joint research agreement for AI·NGS integrated companion diagnosis solution clinical evaluation, signed June 2026. Professor Tae-Jung Kim from the hospital's Pathology Department leads clinical research comparing NGeneBio's AI·NGS solution against global standard Oncoman companion diagnostic products. Plans to file for digital medical device approval by end of 2026.
• Catholic University / YatiriBiocoreStrategic or Co-development Partner · 26 March 2026Three-party MOU for MRD (Minimal Residual Disease) precision diagnosis technology advancement, signed March 2026. NGeneBio provides NGS-based genomic analysis and bioinformatics software; Catholic University Seoul St. Mary's Hospital provides clinical expertise and AML patient samples; YatiriBio (San Diego, proteomics/AI biomarker company) contributes AI-based multi-omics analysis with 5,500+ drug response datasets.
• LG AI ResearchcoreTechnology or Integration · 1 January 2026License agreement for 'EXAONE Path 2.0' EGFR mutation prediction AI model in January 2026. The AI model was applied to NPAS-EGFR, NGeneBio's first AI pathology analysis model, as part of the AI·NGS integrated companion diagnosis solution developed with Catholic University Yeouido St. Mary's Hospital.
• Yonsei Medical CentercoreStrategic or Co-development Partner · 1 September 2025Selected for '2025 Medical AI Data Utilization Voucher Support Project' hosted by KHIDI (Korea Health Industry Development Institute), to develop next-generation immunotherapy response prediction AI solution with Yonsei Medical Center.
• CosmaxBiominorStrategic or Co-development Partner · 1 September 2025Strategic business agreement signed September 2025 with CosmaxBio for gene data-based next-generation health functional food co-development and global market entry.
• Agilent Technologies KoreaminorStrategic or Co-development Partner · 1 July 2025Strategic business agreement signed July 2025 with global diagnostics and life sciences company Agilent Technologies Korea to expand AI SW-based genomic analysis business.
• CILabminorStrategic or Co-development Partner · 1 April 2025Strategic partnership signed April 2025 with Vision AI company CILab for AI-based customized cancer treatment and prediction platform development.
• QuantaMatrixminorStrategic or Co-development Partner · 1 February 2025Strategic business agreement signed February 2025 with in vitro diagnostic technology company QuantaMatrix for dementia diagnosis field.
• Lag3 Genomics (LabGenomics)minorChannel Partner/ Reseller/ Distributor · 1 December 2024NGS diagnostic service development and business cooperation agreement signed December 2022 with Lag3 Genomics through US CLIA lab.
• Seoul Asan HospitalcoreStrategic or Co-development Partner · 1 November 2024Co-developed NGLIS (Next-Generation Genomic Laboratory Information System) which achieved commercial launch and operation at Seoul Asan Hospital in November 2024. Exclusive technology transfer agreement for NGLIS signed in January 2026.
• WHO-PQ Clinical Performance StudyminorStrategic or Co-development Partner · 1 August 2024Selected as a participating company in the WHO-PQ (WHO Pre-qualification) clinical performance test technical support project for in vitro diagnostic medical devices, August 2024.
• Bayer KoreacoreStrategic or Co-development Partner · 1 July 2024Partnership for NGS-based precision diagnostics business expansion and targeted anticancer drug prescription expansion. Joint online symposium on NTRK gene fusion and NGS precision diagnostics held October 2024.
• Euro Alliance (EA), UAEminorChannel Partner/ Reseller/ Distributor · 1 April 2024Technology transfer agreement signed April 2024 for NGS-based precision diagnostic medical device manufacturing technology and lab service know-how to UAE-based Euro Alliance (EA) company.
• UroOuri Children & Women HospitalminorStrategic or Co-development Partner · 1 April 2024Microbiome curation platform business agreement signed February 2022 with UroOuri Children & Women Hospital.
• GenolutionminorStrategic or Co-development Partner · 1 March 2024Strategic business agreement signed March 2024 with molecular diagnostics company Genolution.
• VertyisminorStrategic or Co-development Partner · 1 January 2024Strategic business agreement signed January 2024 with proteomics-based precision medicine company Vertyis for multi-omics-based AI early diagnosis technology development and commercialization.
• Cancer MoonshotminorStrategic or Co-development Partner · 1 October 2023Participated as a member of CancerX under the US Biden administration's Cancer Moonshot initiative since October 2023.
• KeyPleeShop / KT AlphaminorChannel Partner/ Reseller/ Distributor · 1 September 2022Partnership with KT Alpha mobile coupon service KeyPleeShop for Mendels DTC 45 genetic testing analysis kit launch and sales in September 2022.
• Hana BankminorOthers · 1 May 2022Healthcare service provision business agreement signed May 2022 with Hana Bank.
• ParosIBIOminorStrategic or Co-development Partner · 1 January 2021NGS-based companion diagnostics technology development business agreement signed January 2021 with ParosIBIO.

Scale indicators7 records

Recent moves9 records

Expansion highlights7 records

Direct peers

• Guardant Health: Guardant Health is a US-based precision oncology company specializing in NGS-based liquid biopsy and blood-based cancer diagnostics, directly comparable to NGeneBio's ctDNA/MRD panels (MRDaccuPanel AML FLT3, BRCAaccuTest). Both compete in NGS liquid biopsy for cancer detection, MRD monitoring, and treatment selection.
• Foundation Medicine: Foundation Medicine (a Roche subsidiary) is a leading NGS-based comprehensive genomic profiling company for solid tumors, directly comparable to NGeneBio's ONCOaccuPanel (344 genes) and SOLIDaccuTest products. Both serve pharma companion diagnostic needs and oncology clinical decision-making.
• Tempus AI: Tempus AI combines NGS-based molecular profiling with multimodal data (pathology, clinical, RWE) for precision medicine, directly comparable to NGeneBio's G-Hub multimodal AI platform and NPAS AI pathology offering. Both target pharma data partnerships and AI-enabled clinical decision support.
• Burning Rock Biotech: Burning Rock Biotech is a China-based NGS precision oncology company offering cancer gene detection panels and companion diagnostics, closely comparable to NGeneBio's NGS panel portfolio and Asian-market go-to-market approach. Both target cancer diagnostics with focus on Asian patient populations.
• Personalis: Personalis is a US-based NGS cancer genomics company offering tumor profiling and MRD detection, directly comparable to NGeneBio's MRDaccuPanel and solid tumor panels. Both serve pharma CDx development and clinical oncology with NGS-based solutions.

Regional players

• Macrogen: Macrogen is a Korea-headquartered genomic services and NGS company with global operations. Comparable to NGeneBio in NGS-based services, Korean/Asian genomic data assets, and bioinformatics software (NGeneAnalySys vs Macrogen's analysis platforms). Both operate in the Korean precision diagnostics ecosystem.
• Genomedia: Genomedia is a Korean molecular diagnostics and NGS services company, comparable to NGeneBio as a Korean domestic NGS diagnostics competitor. Both target Korean university hospitals with NGS-based cancer panels.

Broad incumbents

• NeoGenomics: NeoGenomics is a US-based clinical laboratory and oncology diagnostics provider offering NGS-based cancer testing, comparable to NGeneBio's US CLIA lab operations (TOPLAB NJ, San Diego). Both serve hospital and pharma clients with NGS-based oncology diagnostics.
• Agilent Technologies: Agilent Technologies is a global life sciences and diagnostics company with which NGeneBio has a strategic business agreement (Jul 2025). Comparable through analytical laboratory instruments, genomics workflows, and bioinformatics software, making Agilent both a partner and broad incumbent.

Emerging players

• MGI Tech: MGI Tech is a China-based global NGS sequencing platform and IVD company with which NGeneBio has a business agreement (Aug 2023). Comparable through NGS instrument/reagent ecosystem and Asian-market diagnostic panels, making MGI both a partner and adjacent competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCPwdgiY5UjyQsz6nlTKBimQ?view_as=subscriber
• LinkedInlinkedin.com/company/ngenebio
• Xx.com/ngenebio
• Facebookfacebook.com/ngenebio

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries4 records

Funding overview

Funding rounds1 record

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about NGeneBio