Access Bio, Inc.
Founded in 2002 and KOSDAQ-listed in 2013, Access Bio develops rapid diagnostic tests for malaria, COVID-19, and other infectious diseases.
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Business overview
Source: DART corporate disclosureFounded in 2002 and listed on KOSDAQ in 2013, Access Bio is a rapid diagnostic test (RDT) company for infectious diseases including malaria and COVID-19. It offers 11 malaria diagnostic products (including a Combo RDT and variant-malaria tests), five COVID-19 diagnostic products (COVID-19 IgG/IgM, COVID-19 antigen test, EZ Covid-19 IgG/IgM, COVID-19 Antigen Home test, and COVID-19 RT-PCR), an ovulation test kit (LH), hepatitis B and C and HIV antibody test kits, and a molecular pneumonia diagnostic kit. It obtained US FDA Emergency Use Authorization for five COVID-19 diagnostic products in 2020-2021, and according to Markets and Markets, the global in-vitro diagnostics market was valued at about USD 109 billion in 2025 and is projected to grow at a 7.6% CAGR through 2030.
Products & technology
- Malaria diagnostic products (11 items, including Combo RDT)Diagnosis of falciparum and variant malaria
- COVID-19 IgG/IgM, COVID-19 antigen test, EZ Covid-19 IgG/IgM, COVID-19 Antigen Home test, COVID-19 RT-PCRCOVID-19 antibody, antigen, and molecular testing
- High-sensitivity malaria diagnostic kitDetection of asymptomatic, low-parasitemia infections
- High-sensitivity COVID-19/flu combo kitSimultaneous COVID-19 and influenza detection
- COVID-19/flu/RSV combo kitSimultaneous COVID-19, influenza, and RSV detection
- Malaria mutation diagnostic kitDetection of malaria parasite mutations not identifiable by existing methods
- Ovulation test kit (LH)Ovulation prediction via luteinizing hormone measurement
- Hepatitis B antigen test, hepatitis C antibody test, HIV antibody testImmunochromatographic detection of infection
- Pneumonia diagnostic kit (molecular)Real-time PCR simultaneous detection of 11 pathogens and 1 mutation across 3 tubes
- H. pylori and clarithromycin-resistance point-mutation detection kit (molecular)Simultaneous detection of H. pylori infection and antibiotic resistance
Regulatory approvals
data.go.kr2 Korean MFDS device approvals · 2010–2014
- MFDSBandage, compression2014-08-06Product approval · Class 1서울 수신 14-2168 호
- MFDSCompression system pump, sequential2010-11-26Product approval · Class 2수인 10-1288 호
R&D and key agreements
Source: DART corporate disclosure고민감도 말라리아 진단키트 · 말라리아 · 미국 판매허가 완료 · Improved-sensitivity product for detecting asymptomatic, low-parasitemia cases
말라리아 돌연변이 진단키트 · 말라리아 기생충 돌연변이 · 임상진행중 · Developing a product to detect mutations that existing methods struggle to identify
폐렴진단키트(분자진단) · 폐렴 · Real-time PCR simultaneous detection of 11 pathogens and 1 mutation in 3 tubes
헬리코박터 내성 동시검출키트(분자진단) · 헬리코박터 감염 · Simultaneous real-time PCR diagnosis of H. pylori and clarithromycin-resistance point mutations
Companies approved for the same productsMedical Devices
Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.
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Sources and updates
- Company basics
- Korea Exchange · DART
- Business content
- Compiled from disclosure filings
- AI visibility
- Measured 2026-08-13
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