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Medical DevicesKOSDAQ 22900032 approvals

Gencurix Inc.

Official website

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

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Business overview

Source: DART corporate disclosure

Gencurix was founded in 2011 and listed on KOSDAQ in June 2020, developing molecular diagnostic products based on liquid biopsy technology. Its products include GenesWell BCT, a breast cancer prognosis test; Droplex EGFR Mutation Test v2, a lung cancer companion diagnostic; and HEPA eDX and COLO eDX for early liver and colorectal cancer detection. GenesWell BCT was recognized as an innovative medical technology in October 2020 and completed 600-patient enrollment in February 2023, while Droplex EGFR Mutation Test v2 obtained MFDS approval in June 2023 and gained insurance coverage from August 2023.

Products & technology

  • GenesWell BCTBreast cancer prognosis test
  • GenesWell ddEGFR Mutation TestLung cancer companion diagnostic test
  • Droplex EGFR Mutation Test v2Lung cancer companion diagnostic (liquid biopsy, detects 100+ mutations)
  • Droplex BRAFThyroid cancer companion diagnostic
  • Droplex KRASColorectal cancer companion diagnostic
  • Droplex POLEEndometrial cancer companion diagnostic
  • HEPA eDXLiver cancer early-detection liquid biopsy product (methylated DNA biomarker-based)
  • COLO eDXColorectal cancer early-detection liquid biopsy product (methylated DNA biomarker-based)

Regulatory approvals

data.go.kr

32 Korean MFDS device approvals · 2015–2026

  • MFDSIVD reagents for extracting nucleic acids2026-07-03
    Product approval · Class 1체외 제신 26-821 호
  • MFDSIVD reagents for cancer related gene2026-05-08
    Product approval · Class 3체외 제허 26-341 호
  • MFDSIVD reagents for cancer related gene2026-05-08
    Product approval · Class 3체외 제허 26-340 호
  • MFDSIVD reagents for cancer related gene2026-05-08
    Product approval · Class 3체외 제허 26-339 호
  • MFDSIVD reagents for companion diagnostics with NAT2026-04-16
    Product approval · Class 3체외 제허 26-289 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 diagnostics2025-11-18
    Product approval · Class 3체외 제허 25-775 호
  • MFDSIVD reagents for cancer related gene2023-10-18
    Product approval · Class 3체외 제허 23-989 호
  • MFDSIVD reagents for companion diagnostics with NAT2023-08-23
    Product approval · Class 3체외 제허 23-861 호
  • MFDSIVD reagents for cancer related gene2023-08-01
    Product approval · Class 3체외 제허 23-812 호
  • MFDSIVD reagents for companion diagnostics with NAT2023-06-05
    Product approval · Class 3체외 제허 23-637 호
  • MFDSIVD reagents for cancer related gene2022-09-07
    Product approval · Class 3체외 제허 22-601 호
  • MFDSIVD reagents for companion diagnostics with NATRevoked2022-07-12
    Product approval · Class 3체외 제허 22-445 호
Show 20 more
  • MFDSIVD reagents for cancer related gene2022-07-06
    Product approval · Class 3체외 제허 22-432 호
  • MFDSIVD reagents for cancer related gene2022-05-26
    Product approval · Class 3체외 제허 22-343 호
  • MFDSIVD reagents for cancer related gene2022-05-20
    Product approval · Class 3체외 제허 22-325 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 diagnostics2022-05-18
    Product approval · Class 3체외 제허 22-315 호
  • MFDSIVD reagents for companion diagnostics with NAT2022-05-09
    Product approval · Class 3체외 제허 22-293 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 diagnostics2022-03-24
    Product approval · Class 3체외 제허 22-207 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 diagnostics2022-01-14
    Product approval · Class 3체외 제허 22-23 호
  • MFDSIVD reagents for cancer related gene2021-12-30
    Product approval · Class 3체외 제허 21-1056 호
  • MFDSSpecimen transport mediaRevoked2021-10-25
    Product approval · Class 1체외 제신 21-1412 호
  • MFDSIVD reagents for cancer related geneRevoked2021-06-25
    Product approval · Class 3체외 제허 21-523 호
  • MFDSIVD reagents for cancer related geneRevoked2021-05-14
    Product approval · Class 3체외 제허 21-380 호
  • MFDSIVD reagents for companion diagnostics with NATRevoked2021-05-14
    Product approval · Class 3체외 제허 21-381 호
  • MFDSIVD reagents for companion diagnostics with NAT2021-05-14
    Product approval · Class 3체외 제허 21-382 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), immunological method2020-08-14
    Product approval · Class 3체외 제허 20-667 호
  • MFDSSpecimen transport media2020-06-04
    Product approval · Class 1체외 제신 20-812 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 20-328 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 diagnostics2020-03-26
    Product approval · Class 3체외 제허 20-222 호
  • MFDSIVD reagents for companion diagnostics with NAT2017-09-20
    Product approval · Class 3체외 제허 17-730 호
  • MFDSIVD reagents for cancer related gene2016-11-02
    Product approval · Class 3체외 제허 16-800 호
  • MFDSOther reagents, classⅠ, for molecular diagnosticsRevoked2015-04-10
    Product approval · Class 2체외 제허 15-532 호

R&D and key agreements

Source: DART corporate disclosure

Droplex 시리즈 확장(PIK3CA, cMET, ESR1, KRAS G12C, NRAS, ALK 등) · 암 동반진단 · Additional Droplex series products beyond EGFR v2, either completed or under development

CTC(순환종양세포) 분리/분석 장비 개발 · Acquired majority stake in CTC isolation/analysis device developer Genobio Corp. in late 2020; mass-production product development ongoing

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Companies approved for the same productsMedical Devices

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

LabGenomics. Co., Ltd.5 shared

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

BIONEERCORPORATION4 shared

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

GC Medical Science Corporation4 shared

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

Genomictree Inc.4 shared

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

HLB PANAGENE Co., LTD.4 shared

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

Median Diagnostics Inc.4 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.

PCL. Inc4 shared

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

RollingStone Co., Ltd.4 shared

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

SD BIOSENSOR INC.4 shared

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

SEEGENE, INC.4 shared

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

CALTH. Inc3 shared

Holds manufacturing approvals for 42 point-of-care diagnostic reagents and devices in the IVD market.

Optipharm.CO.,LTD3 shared

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

Sources and updates

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

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