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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.

As of 2026-10-10, Gencurix Inc. has 32 Korean MFDS device approvals, 35 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

Price

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Market cap

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

Global clinical trials

ClinicalTrials.gov · sponsor-matched

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

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched
Show 25 more publications

Patents

KIPRIS · applicant-matched
Show 77 more patents

AI reads

MAA server logs · IP-verified
94
Times AI engines pulled Gencurix Inc.'s records

Pulled records become part of each AI's index and keep feeding its answers. When an AI cites from that index, nothing reaches our server — so actual citations are uncounted here and exceed this number.

2
Fetched fresh mid-answer

Times an AI needed something not yet in its index and fetched this page fresh while answering. Citations served from the index leave no trace here.

92
Index crawls

Collected as raw material for future answers.

0
Direct AI-tool queries (MCP)

Queries from users who connected this index to their own AI.

12
live 0
Last 7 days
75
live 2
Last 30 days
94
live 2
All time
  • OpenAIChatGPT-Userlive2
  • OpenAIOAI-SearchBot72
  • GoogleGoogleOther9
  • PerplexityPerplexityBot8
  • AnthropicClaudeBot2
  • MicrosoftBingbot1

Measured since Aug 25, 2026 · 5 AI engines · last read Oct 10, 2026

User-agent strings can be forged, so we do not count them at face value. We count only requests matched against vendor-published IP ranges, or confirmed by forward-verified reverse DNS. MCP queries are actual calls to this index's tool endpoint.

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How to connect (MCP)
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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.

HLB PANAGENE Co., LTD.5 shared

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

LabGenomics. Co., Ltd.5 shared

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

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.

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.

COSMAX BTI, INC.4 shared

Founded in 1992 and listed on KOSPI in 2006, COSMAX BTI is the COSMAX Group holding company overseeing health food and cosmetics affiliates.

SEEGENE, INC.4 shared

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

Genomictree Inc.4 shared

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

SD BIOSENSOR INC.4 shared

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

Optipharm.CO.,LTD3 shared

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

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

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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