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