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Biotech & Drug DiscoveryKOSDAQ 109820162 approvals1 trials

GENEMATRIX INC.

Official website

KOSDAQ-listed biotech company developing molecular diagnostics with proprietary C-Tag technology and the NeoPlex product line.

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Business overview

Source: DART corporate disclosure

GeneMatrix was founded in December 2000 and listed on KOSDAQ in November 2009 as a biotechnology company focused on molecular diagnostics and drug development. Using proprietary core technologies including C-Tag, Encleap, TriO, and RFMP, the company develops and sells molecular diagnostic reagents and biochemical reagents, with its NeoPlex product line covering sexually transmitted infections (STI), tuberculosis and non-tuberculous mycobacteria (TB/NTM), human papillomavirus (HPV), respiratory infections (RI), and gastrointestinal infections (GI) as its core product areas. Its multiplex real-time fluorescence analysis technology (C-Tag) enables real-time pathogen detection during gene amplification, and the company is also developing vaccines and immuno-oncology therapeutics for disease prevention and treatment.

Products & technology

  • NeoPlexMultiplex molecular diagnostic product line covering sexually transmitted infections (STI), tuberculosis and non-tuberculous mycobacteria (TB/NTM), human papillomavirus (HPV), respiratory infections (RI), and gastrointestinal infections (GI), detecting multiple pathogens at once
  • Hepatitis B treatment resistance diagnosticDiagnoses resistance to hepatitis B treatment drugs
  • Hepatitis C virus genotyping diagnosticGenotypes hepatitis C virus
  • Cervical cancer-causing virus genotyping diagnosticGenotypes the virus that causes cervical cancer

Regulatory approvals

data.go.kr

162 Korean MFDS device approvals · 2007–2026

  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2026-03-31
    Product approval · Class 3체외 제허 26-243 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2026-03-31
    Product approval · Class 3체외 제허 26-242 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2026-03-31
    Product approval · Class 3체외 제허 26-241 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2025-12-17
    Product approval · Class 3체외 제허 25-849 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2025-10-21
    Product approval · Class 3체외 제허 25-704 호
  • MFDSClinical chemistry automated analyser2023-07-18
    Product approval · Class 1체외 수신 23-1759 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2023-03-13
    Product approval · Class 3체외 제허 23-343 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2022-09-05
    Product approval · Class 3체외 제허 22-594 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2022-07-20
    Product approval · Class 3체외 제허 22-469 호
  • MFDSClinical chemistry automated analyser2022-05-24
    Product approval · Class 1체외 수신 22-913 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2021-11-10
    Product approval · Class 3체외 제허 21-896 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2021-08-27
    Product approval · Class 3체외 제허 21-729 호
Show 68 more
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnosticsRevoked2021-07-27
    Product approval · Class 3체외 제허 21-636 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2021-07-12
    Product approval · Class 3체외 제허 21-586 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2021-07-01
    Product approval · Class 3체외 제허 21-543 호
  • MFDSClinical chemistry automated analyser2021-05-11
    Product approval · Class 1체외 수신 21-827 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2020-10-05
    Product approval · Class 3체외 제허 20-857 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2020-09-29
    Product approval · Class 3체외 제허 20-849 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2020-08-26
    Product approval · Class 3체외 제허 20-744 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2020-08-26
    Product approval · Class 3체외 제허 20-743 호
  • MFDSGeneral calibrators, controls or standards, classⅢ, for clinical chemistryRevoked2020-08-26
    Product approval · Class 3체외 제허 20-742 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2020-08-26
    Product approval · Class 3체외 제허 20-741 호
  • MFDSGeneral calibrators, controls or standards, classⅢ, for clinical chemistryRevoked2020-08-26
    Product approval · Class 3체외 제허 20-739 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2020-08-26
    Product approval · Class 3체외 제허 20-740 호
  • MFDSGeneral calibrators, controls or standards, classⅢ, for clinical chemistryRevoked2020-08-26
    Product approval · Class 3체외 제허 20-749 호
  • MFDSGeneral calibrators, controls or standards, classⅢ, for clinical chemistryRevoked2020-08-26
    Product approval · Class 3체외 제허 20-748 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide useRevoked2020-08-26
    Product approval · Class 3체외 제허 20-747 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide useRevoked2020-08-26
    Product approval · Class 3체외 제허 20-746 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide useRevoked2020-08-26
    Product approval · Class 3체외 제허 20-745 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide use2020-08-11
    Product approval · Class 2체외 제인 20-4739 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide use2020-08-11
    Product approval · Class 2체외 제인 20-4737 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide use2020-08-11
    Product approval · Class 2체외 제인 20-4736 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide useRevoked2020-08-11
    Product approval · Class 2체외 제인 20-4735 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide useRevoked2020-08-11
    Product approval · Class 2체외 제인 20-4734 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide useRevoked2020-08-10
    Product approval · Class 2체외 제인 20-4728 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide useRevoked2020-08-10
    Product approval · Class 2체외 제인 20-4727 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide useRevoked2020-08-10
    Product approval · Class 2체외 제인 20-4726 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide useRevoked2020-08-10
    Product approval · Class 2체외 제인 20-4725 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide useRevoked2020-08-10
    Product approval · Class 2체외 제인 20-4724 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide useRevoked2020-08-10
    Product approval · Class 2체외 제인 20-4723 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide use2020-08-10
    Product approval · Class 2체외 제인 20-4722 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide use2020-08-10
    Product approval · Class 2체외 제인 20-4729 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnosticsRevoked2020-06-03
    Product approval · Class 3체외 제허 20-438 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2020-04-28
    Product approval · Class 3체외 제허 20-336 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnosticsRevoked2020-03-20
    Product approval · Class 3체외 제허 20-199 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2020-03-16
    Product approval · Class 3체외 제허 20-184 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnosticsRevoked2019-12-19
    Product approval · Class 3체외 제허 19-827 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2019-03-27
    Product approval · Class 3체외 제허 19-190 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2018-11-14
    Product approval · Class 1체외 제신 18-1526 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-11-06
    Product approval · Class 3체외 제허 18-722 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2018-09-04
    Product approval · Class 1체외 제신 18-1148 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-07-27
    Product approval · Class 3체외 제허 18-538 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnosticsRevoked2018-07-17
    Product approval · Class 3체외 제허 18-503 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2018-05-17
    Product approval · Class 1체외 제신 18-619 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2017-11-02
    Product approval · Class 3체외 제허 17-834 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2017-07-11
    Product approval · Class 3체외 제허 17-484 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnosticsRevoked2017-02-15
    Product approval · Class 3체외 제허 17-115 호
  • MFDSIVD reagents for general immune testRevoked2016-09-27
    Product approval · Class 2체외 제인 16-721 호
  • MFDSIVD reagents for general immune testRevoked2016-09-23
    Product approval · Class 2체외 제인 16-716 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2016-09-12
    Product approval · Class 1체외 수신 16-2388 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-06-16
    Product approval · Class 1체외 제신 16-739 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-06-16
    Product approval · Class 1체외 제신 16-738 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-04-21
    Product approval · Class 1체외 제신 16-489 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-03-10
    Product approval · Class 1체외 제신 16-291 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-03-10
    Product approval · Class 1체외 제신 16-289 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-03-10
    Product approval · Class 1체외 제신 16-288 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-03-10
    Product approval · Class 1체외 제신 16-287 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-03-10
    Product approval · Class 1체외 제신 16-286 호
  • MFDSIVD reagents for infectious inflammatory testsRevoked2015-07-23
    Product approval · Class 2체외 제인 15-1223 호
  • MFDSIVD reagents for autoimmune diseaseRevoked2015-06-18
    Product approval · Class 2체외 제인 15-965 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-05-29
    Product approval · Class 1경인 체외 제신 15-279 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-05-29
    Product approval · Class 1경인 체외 제신 15-278 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-04-24
    Product approval · Class 1경인 체외 제신 15-193 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-04-24
    Product approval · Class 1경인 체외 제신 15-192 호
  • MFDSIVD reagents for general immune test2015-01-14
    Product approval · Class 2체외 제인 15-49 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-01-09
    Product approval · Class 1경인 체외 제신 15-12 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-01-09
    Product approval · Class 1경인 체외 제신 15-11 호
  • MFDSIVD reagents for autoimmune diseaseRevoked2014-11-19
    Product approval · Class 2체외 제인 14-2303 호
  • MFDSIVD reagents for general immune test2014-11-19
    Product approval · Class 2체외 제인 14-2304 호
  • MFDSIVD reagents for general immune test2014-03-13
    Product approval · Class 2체외 제인 14-608 호

Showing the 80 most recent of 162 records.

Clinical trials

data.go.kr

1 MFDS clinical trial authorisations · 2025 (Phase 1 1)

  • Phase 1GMAI-022025-04-18

    1 trial site

Not yet compiled: business overview · R&D. Send us materials and we will add them

Companies approved for the same productsBiotech & Drug Discovery

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

Boditech Med Inc.19 shared

KOSDAQ-listed point-of-care immunodiagnostics company supplying diagnostic cartridges and the ichroma/AFIAS instrument series.

GC Medical Science Corporation15 shared

GC Medical Science Corporation, KOSDAQ-listed since 2014, operates diagnostic reagent, blood glucose, and hemodialysis solution businesses.

SD BIOSENSOR INC.13 shared

KOSPI-listed in-vitro diagnostics company known for the STANDARD Q antigen/antibody test kits.

HUMASIS CO., LTD.12 shared

KOSDAQ-listed IVD company producing COVID-19 and HIV point-of-care diagnostic reagents alongside rubber products and entertainment businesses.

NanoenTek,Inc.12 shared

Founded in 1987 and listed on KOSDAQ in 2000, NanoenTek develops Lab-On-a-Chip in-vitro diagnostic devices and life science instruments.

OSANG HEALTHCARE CO.,LTD.12 shared

Founded 1996, listed on KOSDAQ in 2024, OSANG HEALTHCARE develops and sells biochemistry, immunodiagnostic, and molecular IVD products.

Sugentech, Inc.11 shared

Founded in 2011 and KOSDAQ-listed in 2019, Sugentech develops multiplex immunoblot, point-of-care, and digital healthcare diagnostics.

Precision Biosensor Inc.8 shared

KOSDAQ-listed IVD company producing time-resolved fluorescence immunodiagnostic products under the Exdia TRF brand.

i-SENS, Inc.7 shared

Founded in 2000 and KOSDAQ-listed in 2013, i-SENS makes blood glucose monitors and point-of-care testing devices.

PCL. Inc6 shared

KOSDAQ-listed IVD company using SG Cap™ multiplex diagnostic technology for infectious disease, cancer, and companion animal testing.

TASCOM Co.,Ltd.6 shared

Develops SimplexTAS, a point-of-care clinical chemistry and immunoassay analyzer for IVD testing.

PROTIA INC.5 shared

KOSDAQ-listed in-vitro diagnostics company selling PROTIA Allergy-Q allergy diagnostic products domestically and in 80+ countries.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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