Signed a licensing agreement with LG AI Research for EXAONE Path 2.0, an AI model for EGFR mutation detection.

Signed an exclusive technology transfer agreement for NGLIS, a next-generation genomic laboratory information system jointly developed with Asan Medical Center.

Approved the merger of subsidiary NGene Pharma.

Selected for the 2025 Medical AI Data Utilization Voucher Support Program led by the Korea Health Information Service (KHIS), and initiated development of an AI solution for predicting immunotherapy response in collaboration with Yonsei Medical Center.

Signed a strategic partnership agreement with Cosmax Bio to jointly develop next-generation health functional foods based on genetic data and to expand into global markets.

Acquired 100% equity ownership of Nuripharm, a pharmaceutical distribution company, and renamed the entity to NGene Pharma.

Signed an MOU with Agilent Technologies Korea, Inc., a global diagnostics and life sciences company, to expand AI software-based genomic data analysis.

Registered a patent in Singapore for an RNA precision diagnostics product analysis algorithm that detects oncogenic fusion variants.

Changed the major shareholder (from KT Corp. to SH Healthcare Investment No.1 Partnership Fund).

Signed a strategic partnership agreement with CV Lab, a vision AI company, to develop an AI-based precision cancer diagnosis and prediction platform.

Obtained manufacturing approval from the Ministry of Food and Drug Safety for MRDaccuPanel™ AML FLT3, a precision diagnostic product jointly developed with Seoul National University Hospital that enables high-s ensitivity simultaneous detection of FLT3-ITD and FLT3-TKD mutations in blood cancer patients.

Supplied genomic precision diagnostics products to five major hospitals in Vietnam, achieving the leading market position in Vietnam.

Signed a strategic partnership agreement with Quantametrics, an in vitro diagnostics company, to collaborate on dementia diagnostic technologies.

Recognized as an Innovative Medical Device Company under the Ministry of Health and Welfare’s innovative medical device designation program.

Registered two patents related to the analysis of health and exercise traits using genetic data.

Registered two Korean patents for SNP marker technologies for diagnosing dementia associated with Parkinson’s disease (PDD) and dementia with Lewy bodies (DLB), the first such technologies developed in Korea.

Passed the post-market surveillance audit for EN ISO 13485:2016 medical device quality management system certification.

Filed U.S. and European patent applications for high-sensitivity assay technologies detecting FLT3 gene variants, a key biomarker in acute myeloid leukemia (AML).

Launched NGLIS, a next-generation genomic laboratory information system, at Asan Medical Center.

Filed a Japanese patent on body fluid-based diagnostic and monitoring technology targeting neurodegenerative diseases.

Co-hosted an online symposium with Bayer Korea on the latest trends in NTRK gene fusion-based NGS precision diagnostics.

Filed a patent for an algorithm detecting high-sensitivity FLT3 mutations for personalized blood cancer treatment.

Selected as a participating company in a government-supported program providing technical support for clinical performance testing of in vitro diagnostic medical devices for WHO-PQ certification.

Registered a patent for a composite omics analysis technology to deliver personalized health improvement content.

Signed an MOU with Bayer Korea to expand the NGS precision diagnostics business and broaden indications through companion diagnostics.

Signed a technology transfer agreement with EuroAlliance (EA), a UAE-based distributor, covering NGS-based precision diagnostic medical device manufacturing technologies and laboratory service know-how.

Acquired TOPLAB, a CLIA-certified laboratory based in New Jersey, USA.

Changed the major shareholder (from Gencurix to KT Corp.).

Acquired a CLIA-certified laboratory located in San Diego, California, USA.

Signed a strategic partnership agreement with Genolution, a molecular diagnostics company.

Withdrew ISO 9001:2015 quality management system certification.

Signed an MOU with BERTIS Inc., a precision medical device company specializing in proteomics, to collaborate on the development and commercialization of multi-omics-based AI early diagnostics technologies.

Registered a Korean patent for NGS-based tuberculosis diagnostic technology.

Registered a German patent for leukemia molecular diagnostic technology based on PHB gene detection in blood.

Established NGeneBio USA Holdings to oversee U.S. operations.

Joined the Cancer Moonshot initiative as a member of CancerX under the Biden administration.

Filed a U.S. patent on body fluid-based diagnostic and monitoring technology targeting neurodegenerative diseases.

Signed an MOU with MGI for global NGS equipment partnership.

Renewed ISO 13485:2016 certification for the 7th consecutive year.

Renewed ISO 27001:2013 certification for the 3rd consecutive year.

Acquired a patent for customized infant growth solutions using the gut microbiome.

Signed an MOU with Agilent Technologies Korea, Inc. to expand domestic and global NGS precision diagnostics markets.

Launched 'na-e' mobile app for personal genetic testing service and convenient health care of customers

Received certification approval for 70 items(the highest number among evaluation agencies) in the Korea Ministry of Health and Welfare's "Direct Implementation Genetic Testing Capacity Certification System"

Signed an MOU with Labgenomics for NGS diagnostic service development and business at CLIA Lab.

Signed an MOU with NUPCO in Saudi Arabia on providing HEMEaccuTest

Release and sale of the first DTC mobile gift card in Korea (Mendel’s DNA45 service)

Signed an MOU with Genoks in Turkey for NGS services in the Middle East

Entered the global PCR market based on an MOU with Invites BioCore

Acquired manufacturing approval for NGenPlex™ nCoV/FluA.B Detection Kit (diagnostic reagent for COVID-19 and influenza) (for export only)

Signed an MOU with Hana Bank on providing healthcare services

Registered CE-IVD for the first time in Asia for MTBaccuPanel™ (precision diagnostic product for tuberculosis)

Registered CE-IVD for ONCOaccuPanel™ (Comprehensive genomic profiling for solid tumor)

Signed an MOU with Woori Children's Hospital on a microbiome curation platform

Acquired the Innovative Medical Device Company Certification from the Ministry of Health and Welfare

Passed the evaluation of the Ministry of Health and Welfare’s 3rd pilot project for the introduction a certification system for direct-to-consumer (DTC) genetic testing service (70 items)

Acquired CE-IVD for HLAaccuTest™ All (NGS-based histocompatibility test product) (List B)

Acquired manufacturing approval for BRCAaccuTest™ PLUS (precision diagnostic product for breast/ovarian cancer) from the Korean Ministry of Food and Drug Safety

Conducted a molecular epidemiologic study on metastatic prostate cancer in Koreans with Asan Medical Center

Acquired manufacturing approval for HLAaccuTest™ (NGS-based histocompatibility test product) from the Korean Ministry of Food and Drug Safety

Acquired manufacturing approval for HLAaccuTest™ All (NGS-based histocompatibility test product) (for export)

Acquired manufacturing approval for SOLIDaccuTest™ DNA HRD (solid tumor precision diagnostic product) (for export)

Acquired manufacturing approval for BRCAaccuTest™ PLUS (precision diagnostic product for breast/ovarian cancer) (for export)

RegisteredCE-IVD for NGenPlex™ nCoV/FluA.B Detection Kit (diagnostic reagent for COVID-19 and influenza)

Signed an MOU with Pharos iBio to develop NGS-based companion diagnostic technology

Listed on KOSDAQ

Acquired the ISO/IEC 27001:2013 certification (Information security management system standard certification)

Acquired manufacturing approval for NGenPlex™ nCoV qRT-PCR Kit (COVID-19 diagnostic reagent) (for export)

Registered CE-IVD for NGenPlex™ nCoV qRT-PCR Kit (COVID-19 diagnostic reagent)

Acquired manufacturing approval for HEMEaccuTest DNA (precision diagnostic product for blood cancer) (for export)

Acquired manufacturing approval for SOLIDaccuTest™ DNA (precision diagnostic product for solid tumor) (for export)

Registered CE-IVD for the first time in Korea for HEMEaccuTest™ DNA (precision diagnostic product for blood cancer)

Selected as a prospective unicorn company (hosted by the Ministry of SMEs and Startups / supervised by the Korea Technology Finance Corporation (Kibo))

Acquired the medical device quality management system (EN ISO 13485:2016) certification

Designated as a clinical trial sample analysis institute by the Ministry of Food and Drug Safety

Acquired quality management system (ISO 9001:2015) certification

Registered CE-IVD for the first time in Korea for SOLIDaccuTest™ DNA (precision diagnostic product for solid tumor)

Acquired manufacturing approval for the first time in Korea for BRCAaccuTest™ (precision diagnostic product for breast/ovarian cancer) from the Ministry of Food and Drug Safety

Registered CE-IVD for BRCAaccuTest™ PLUS (precision diagnostic product for breast/ovarian cancer)

Registered CE-IVD for the first time in Korea for BRCAaccuTest™ (precision diagnostic product for breast/ovarian cancer

Registered CE-IVD for NGenAnalySys (analytical software)

Additionally acquired the Conformity with the Korea Good Manufacturing Practice (in vitro diagnostic medical device)

Acquired the EN ISO 13485 certification for the NGS reagent panel and software

Acquired the general industrial quality management system (ISO 9001:2008) certification

Acquired the Korea Good Manufacturing Practice (KGMP; certification of conformity with medical device manufacturing and quality control standards) certification for the NGS reagent panel and software

Establishment of NGeneBio