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Medical DevicesKOSDAQ 3048404 approvals

PeopleBio, Inc.

Official website

KOSDAQ-listed IVD company selling AlzOn and AlzOn+ blood-based oligomeric beta-amyloid tests for Alzheimer's risk assessment.

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Business overview

Source: DART corporate disclosure

Founded in 2002 and listed on KOSDAQ in 2020, PeopleBio is an in-vitro diagnostics medical device company. Using its MDS technology to quantitatively measure oligomeric beta-amyloid (OAβ) in blood plasma for Alzheimer's disease risk assessment, it sells the domestic AlzOn test and the export AlzOn+ test. AlzOn received Korean MFDS Class 2 medical device approval in April 2018 and new health technology recognition in December 2021, while AlzOn+ obtained CE marking in November 2020, and the company has signed exclusive 5-10 year supply agreements covering Hungary, Malaysia, Thailand, China, Australia, and the Netherlands.

Products & technology

  • AlzOnblood plasma oligomeric beta-amyloid (OAβ) quantitative test for Alzheimer's risk assessment (domestic)
  • AlzOn+blood plasma oligomeric beta-amyloid (OAβ) quantitative test for Alzheimer's risk assessment (export)

Regulatory approvals

data.go.kr

4 Korean MFDS device approvals · 2017–2023

  • MFDSChemiluminescence assay(CLIA) analyzer2023-02-03
    Product approval · Class 1체외 제신 23-139 호
  • MFDSIVD reagents for general immune test2018-04-23
    Product approval · Class 2체외 제허 18-289 호
  • MFDSIVD reagents for general immune test2017-11-21
    Product approval · Class 2체외 제인 17-4891 호
  • MFDSIVD reagents for general immune testRevoked2017-05-10
    Product approval · Class 2체외 제인 17-4332 호

R&D and key agreements

Source: DART corporate disclosure

OAβ 검사제품 임상시험 · 알츠하이머병 임상진단 보조 · 임상 완료(2017년 품목허가용 임상시험계획서 승인) · Clinical sensitivity and specificity evaluated at Seoul National University Bundang Hospital and Chung-Ang University Hospital

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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.

Boditech Med Inc.2 shared

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

GC Medical Science Corporation2 shared

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

SD BIOSENSOR INC.2 shared

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

Amicogen, Inc.1 shared

KOSDAQ-listed industrial biotech producing cephalosporin precursor enzyme CX and antibody-purification Protein A resin.

GENEMATRIX INC.1 shared

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

HUMASIS CO., LTD.1 shared

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

Micro Digital Co., Ltd.1 shared

KOSDAQ-listed bioprocess and biomedical company supplying the CELBIC single-use cell culture system and the DxBIC automated analysis system.

NKGen Biotech Korea Co., Ltd.1 shared

NKGen Biotech Korea licenses out NK cell therapy patents to NKGen Biotech Inc. and provides immune diagnostic and healthcare products.

PCL. Inc1 shared

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

PROTIA INC.1 shared

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

QuantaMatrix Incorporated1 shared

Established in 2010, listed on KOSDAQ in 2020, QuantaMatrix develops dRAST and QDST antimicrobial susceptibility testing systems.

TASCOM Co.,Ltd.1 shared

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

Sources and updates

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

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