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Medical DevicesKOSDAQ 228760Innovative Medical Device17 approvals

Genomictree Inc.

Official website

Cancer molecular diagnostics company behind the EarlyTect-C stool-based colorectal cancer test using the SDC2 methylation biomarker.

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Business overview

Source: DART corporate disclosure

Founded in 2000 and listed on KOSDAQ in 2019, the company is a cancer molecular diagnostics firm based on DNA methylation biomarkers. It received MFDS approval in 2018 and launched in 2019 its stool-based colorectal cancer test 'EarlyTect Colorectal Cancer (EarlyTect-C),' which uses the SDC2 gene methylation marker to deliver results within 8 hours. Consolidated 2025 revenue was KRW 3.76 billion, up 59.2% year-on-year, and the company is expanding overseas through its 2019 US subsidiary Promis Diagnostics and a 2020 technology license to Shandong Lukang Haoliyou in China.

Products & technology

  • EarlyTect-CStool-based colorectal cancer adjunctive diagnostic test
  • EarlyTect bladder/lung cancer diagnosticsBladder and lung cancer adjunctive diagnostic biomarkers

Regulatory approvals

data.go.kr

1 Innovative Medical Device designations · 2024 / 16 Korean MFDS device approvals · 2014–2026

  • InnovativeGT-BC2-12024-03-19
    Innovative Medical Device designation
  • MFDSIVD reagents for cancer related gene2026-01-08
    Product approval · Class 3체외 제허 26-19 호
  • MFDSSpecimen transport media2024-04-24
    Product approval · Class 1체외 제신 24-508 호
  • MFDSSpecimen transport media2023-01-04
    Product approval · Class 1체외 제신 23-13 호
  • MFDSSpecimen transport media2023-01-04
    Product approval · Class 1체외 제신 23-12 호
  • MFDSIVD reagents for extracting nucleic acids2021-08-26
    Product approval · Class 1체외 제신 21-1177 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 diagnostics2021-06-17
    Product approval · Class 3체외 제허 21-487 호
  • MFDSIVD reagents for extracting nucleic acids2021-04-07
    Product approval · Class 1체외 제신 21-468 호
  • MFDSSpecimen transport media2021-03-31
    Product approval · Class 1체외 제신 21-427 호
  • MFDSSpecimen transport media2020-08-20
    Product approval · Class 1체외 제신 20-1253 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 diagnostics2020-04-14
    Product approval · Class 3체외 제허 20-288 호
  • MFDSIVD reagents for cancer related gene2019-12-10
    Product approval · Class 3체외 제허 19-814 호
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  • MFDSSpecimen transport media2019-06-03
    Product approval · Class 1체외 제신 19-724 호
  • MFDSIVD reagents for cancer related gene2018-08-28
    Product approval · Class 3체외 제허 18-593 호
  • MFDSIVD reagents for extracting nucleic acids2018-07-02
    Product approval · Class 1체외 제신 18-792 호
  • MFDSIVD reagents for cancer related geneRevoked2018-01-03
    Product approval · Class 3체외 제허 18-6 호
  • MFDSOther reagents, classⅡ, for molecular diagnostics2014-04-14
    Product approval · Class 2체외 제허 14-854 호

R&D and key agreements

Source: DART corporate disclosure

SDC2 유전자 메틸화 마커 · 대장암 · 상용화(얼리텍-C) · Proprietary biomarker; delivers results within 8 hours (vs. ~26 hours for Cologuard)

대장암·방광암 보조진단 제품 미국 FDA 승인 · 대장암, 방광암 · 임상시험 및 승인 절차 진행 예정 · Clinical trials and approval process planned for US FDA approval alongside Korean MFDS approval

Not yet compiled: business overview. Send us materials and we will add them

Companies approved for the same productsMedical Devices

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

BIONEERCORPORATION5 shared

Bioneer, founded in 1992 and KOSDAQ-listed in 2005, provides gene analysis equipment, molecular diagnostics, and RNAi drug development.

Gencurix Inc.4 shared

Founded 2011, KOSDAQ-listed 2020, Gencurix develops liquid-biopsy diagnostics: breast cancer prognosis and lung/colorectal companion tests.

LabGenomics. Co., Ltd.4 shared

KOSDAQ-listed molecular genetic diagnostics company providing NGS-based non-invasive prenatal testing (NIPT) under the MomGuard brand.

SEEGENE, INC.4 shared

Founded in 2000 and KOSDAQ-listed in 2010, Seegene develops syndromic multiplex PCR molecular diagnostic reagents.

GC Medical Science Corporation3 shared

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

HLB PANAGENE Co., LTD.3 shared

Founded in 1976 and KOSDAQ-listed in 2000, HLB PANAGENE develops PNA-based molecular diagnostic and diagnostic automation products.

Median Diagnostics Inc.3 shared

Founded in 1999 and listed on KONEX in 2017, Median Diagnostics develops and manufactures immunoassay, molecular, and point-of-care in vitro diagnostic kits for animal diseases.

Optipharm.CO.,LTD3 shared

Optipharm, founded in 2000 and KOSDAQ-listed in 2018, provides animal disease diagnostics, animal medicine, and biotech.

PCL. Inc3 shared

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

RollingStone Co., Ltd.3 shared

KOSDAQ-listed in-vitro diagnostics company developing the LabChip-based VERI-Q molecular diagnostic device series.

SD BIOSENSOR INC.3 shared

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

Boditech Med Inc.2 shared

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

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-14

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