Company History
2008 - 2013
Multi-Diagnostic Platform Technology and Production Infrastructure
2014 - 2016
Certification Acquisition and Clinical / Licensing / Investment Attraction
2017 - 2019
Establishing a platform to enter the global market by listing and selecting projects
2020 - present
Expanding Global market share
- 2008
- 02 Established PCL Co., Ltd.
- 10 Corporate research institute certification
- 2009
- 04 Signed MOU with German Scienion AG
- 06 Selected as a supervising institution
for international quantum joint research project - 07 Built Pilot production facility with Scienion AG
- 12 SolB™ Reagent released
- 2011
- 08 Secure large-scale production facilities
and build mass production system
Completed development of Multiplex Diagnostic Platform - 10 Signed an MOU with Scienion AG, Germany for mass production
- 2012
- 03 Attracting foreign investment: 1.5 billion KRW
(Global Biomedical New Growth Engine Investment Fund)
- 2013
- 04 GMP Certification by the Ministry of Food and Drug Safety
- 07 ISO 13485 Certification
- 11 Investment attractions: 4.5 billion KRW
(Venture Investment Association, etc.)
- 2014
- 02 HIV – HCV multiplex kit clinical trial
(Korea University Guro Hospital, Department
of Diagnostic Laboratory Medicine) - 05 Medical device manufacturing license / Hi3-1 license for export
- 11 Signed a global clinical trial contract with the Ministry
of Health and Welfare
- 2015
- 04 Signed a collaboration agreement with Brazilian REM
- 08 Investment attraction: 15.5 billion KRW
- 09 Multinational clinical initiation for CE certification (LIST A)
- 10 Signed MOU with Orasure Technology, a NASDAQ listed company
- 12 Received Minister's Award at Korea Technology Awards
- 2016
- 01 Submit a CE Certified Technical Report
- 02 CE Audit (Germany TUV) completed
- 04 GMP certification for domestic sales
- 08 Capital increase of 4.8 billion KRW
- 09 Passed the technology evaluation
(Korea Health Industry Development Institute,
Nice Credit Evaluation) - 09 Hi3-1 Approval of manufacturing device
for medical device class 4 in Korea - 10 Approval of preliminary screening of KOSDAQ
- 12 Acquired new health technology (NET) certification
and family-friendly certification
- 2017
- 01 Announcement of Biotech Showcase,
JP Morgan Healthcare conference - 02 Listed on KOSDAQ (Technology Special Listed Company)
- 07 Hi3-B CMC clinical trial
- 11 Clinical trial conducted with Cerba, France
- 12 Selected as Korea-Switzerland International
Joint Technology Development Project
by Ministry of Trade, Industry and Energy
- 2018
- 01 Declaration of HiSU system, HiSU system 2.0, HiSU2005e
- 03 Selected as a promising bio IP business by the Ministry of Trade,
Industry and Energy - 04 Hi3-B CE Accepted / Ci-5 CE Accepted
- 06 Accepted manufacturing approval of Ci-5 KFDA
- 08 Acquisition of Veterinary Medical Device Manufacturing
Business License Report
on the manufacture of veterinary medical devices
(immunofluorescence device, PCLOK-PET) - 09 Hi3 American Red Cross IRB Approval
- 2019
- 07 Gain CE certification for Ci-5
- 09 Public Procurement Service's Selection of 'Innovative Prototype’
- 2020
- 04 COVID-19 Product Development and Export Permit, CE Certification
Obtain the FDA's item authorization for Ci-5
COVID-19 Exports Products to More than 40 Countries - 05 Launching COVID19 Diagnostic Total Solution
Export COVID19 diagnostic products to more than 50 countries - 09 Successful Q3 Revenue Surplus Transition
- 10 Domestic Blood Testing Center Opening
- 11 National Team of Innovative Companies of the Ministry of Health
and Welfare selected 1000 national team members
Designating a Government Innovative Medical Company - 12 LG Chem, Dong-A ST, SIEMRNS and Red Cross
Concluding an MOU agreement for bidding
for the immune examination system
- 2021
- 01 Designation of Multi-immune Diagnostic
Technology National Core Technology - 02 Minister of Health and Welfare commendation.