May

• Received IVDR approval for IntelliPlex™ 1000 πCode Processor
• Received IVDR approval for PlexBio™ 100 Fluorescent Analyzer

Dec

• Received trademark approval in Taiwan for “IntelliPrep”

Oct

• Launched IntelliPlex™ Lung Cancer Panel with IntelliPlex Platform in BioAsia Taiwan
• Patent filed in Singapore for “Image differentiated multiplex assays”

Sep

• Patent filed in Japan for “Image differentiated multiplex assays”
• Success sales to Shanghai Yikon Medical Laboratory Co., Ltd. for IntelliPlex Lung Cancer Panel
• Patent filed in Taiwan for “Image differentiated multiplex assays”

Aug

• Received trademark approval in Japan for “IntelliPlex” (word mark)
• Success regular sales to LIHPAO LIFE SCIENCE CORP for Automated Nucleic Acid ExtractionSystem and IntelliPlex™ SARS-CoV-2 Extraction Kit
• Collaboration with Chiang Mai University, Thailand forπCode assay development on IntelliPlex Platform

Jul

• Patented filed in AUS for “Image differentiated multiplex assays”

Jun

• Launched IntelliPlex™ SARS-CoV-2 Variant Analysis Kit both in Taiwan and Japan

Apr

• Received FSC for IntelliPlex™ SARS-CoV-2 Detection Test Kit
• Success co-development with Denka Seiken Co. Ltd. for IntelliPlex™ SARS-CoV-2 Variant Analysis Kit
• Received TFDA approval for IntelliPlex™ SARS-CoV-2 Detection Test Kit

Feb

• Membership of 5th Liquid Biopsy for Precision Oncology Summit

Jan

• Patent filed in US for “Image differentiated multiplex assays for multiplex detection of DNA mutations”
• Received FSC for IntelliPlex™ SARS-CoV-2/Flu Kit
• Success sales to SHUWEN BIOTECH CO., LTD. for IntelliPlex Lung Cancer Panel

 

Dec

• Received CE-IVD Mark for IntelliPlex™ SARS-CoV-2/Flu Kit

• Development Program of Automated Multi-Respiratory Pathogens Detection System received subsidy from "Industrial Upgrading Innovation Platform Guidance Program" by Industrial Development Bureau

Aug

• Received TFDA manufacturing approval for IntelliPlex™ SARS-CoV-2 Detection Test Kit

Jun

• Received FDA EUA approval for IntelliPlex™ SARS-CoV-2 Detection Test Kit

• Received TFDA class 2 IVD certificate for IntelliPlex™ HCV Genotyping Kit (Registration Number: MPHW-MD-No. 006709)

May

• Received TFDA export sales certificate and CE-IVD Mark for IntelliPlex™ SARS-CoV-2 Detection Kit

Apr

• Received Financial Times Top 500 Asia-Pacific High-Growth Companies recognition

Jan

• Received Deloitte Technology Fast 500 Asia Pacific recognition for three consecutive years

Dec

• Research results of HIV diagnostics assays by technology licensing published on Journal of AIDS and Treatment  

Nov

• Passed ISO 13485:2016 auditing- received certification renewal

Jul

• Clinical trial results of IntelliPlex™ KRAS G12/13 Mutation Kit published on journal of Molecular Diagnosis & Therapy

• Clinical trial results of IntelliPlex™ HCV Genotyping Kit published on journal of Diagnostic Microbiology and Infectious Disease

• Dr. Felicioni presented and recommended IntelliPlex™ Lung Cancer Panel in conference of Patologia Medicina Molecolare Predittiva

Jun

• A. Menarini Diagnostics (Italy) signed Exclusive Distribution Agreements for the IntelliPlex™ Instrument System and Reagents sales in western Europe, the Middle East, and Australia.

May

• Biogenetix (Romania) signed Exclusive Distribution Agreements for the IntelliPlex™ Instrument System and Reagents

• Promoted IntelliPlex™ Instrument System in infectious disease applications to the National University of Singapore Medicine by Dr. Stuart Palmer (COO)//

Mar

• Launched IntelliPlex™ Lung Cancer Panel for liquid biopsy applications in Molecular & Precision Med Tri-Conference 2019

Feb

• Denka Seiken Co. Ltd. signed Licensing Agreement for IntelliPlex™ Instrument

 

Oct
PlexBio Received CE-IVD Mark for IntelliPlex™ Lung Cancer Panel

Aug
Received TFDA Licenses for IntelliPlex™ KRAS and KRAS+ Mutation Kits
Denka Signed Distribution Agreements with PlexBio for the IntelliPlex™ Instrument System and Reagents

May
Euroclone Signed Distribution Agreements with PlexBio for the IntelliPlex™ Instrument System and Reagent
University "G. D'Annunzio" of Chieti Presented Data on PlexBio Technology at Molecular Diagnostic Europe Conference

Jan
PlexBio received Deloitte Technology Fast 500 Asia Pacific recognition - Ranks Among Top Growing Companies in the Asia Pacific
PlexBio Expanded Collaboration with Denka to Co-Develop an Infectious Disease Diagnostic System

Dec
IntelliPlex™ HCV Genotyping Kit finished clinical trial, began database lock
Passed ISO 13485:2003 SGS auditing- received certification renewal

Nov
Received CE-IVD approval for IntelliPlex™ ROS 1, RET/NTRK1 Rearrangement Kit, IntelliPlex™ KRAS Plus Mutation Kit, IntelliPlex™NRAS Mutation Kit

Sep
Received CE-IVD approval for IntelliPlex™ 1000 πCode Processor

Apr
Received CE-IVD approval for IntelliPlex™ ALK Rearrangement Kit and HPV Genotyping Kits
PlexBio made its debut in presenting IntelliPlex CE-IVD reagents and test results to the scientific community at Molecular Diagnostics Europe conference

Mar
Received TFDA certification for IntelliPlex™ 1000 πCode Processor

Feb
Received TFDA certification for PlexBio™ 100 Fluorescent Analyzer 100 Fluorescent Analyzer
 

Sep
 License agreements signed with Denka Seiken Co.. Ltd.

Feb
Listed company at Taiwan emerging stock market

Jan
Supplemental public issuance took effect
Completed nCode MicroDisc development

Nov
Completed a round of fund-raising of NTD $350 million at $35 per share; total of NTD $508 million paid-in capital was rais

Apr
Obtained CE certificates for bDNA HPV ~ KRAS ' BRAF ~ EGFR and wash station
KRAS clinical trial began

Feb
Introduced PlexBo Wash Station

Jan
FISH Probe Kit passed ISO 9001 and ISO 13485
Obtained TFDA's approval for TERC and HERZ

Dec
Obtained CFDA's import license for PlexBio Analyzer
Qualified for GMP Production of IHC reagents and Kits

Feb
Complete a round of fund-raising of NTD $272 million at $22 per share, total of NTD $380 million paid-in capital was raised
 

Dec
Establishment of Jiangsu PlexBio Medical Technology Co., Limited. Introduced PlexBio Thermocycler

Aug
Obtained TFDA's approval for PlexBio Analyzer

Jul
Obtained ISO 9001, ISO 13485, GMP, and CE Certifications for PlexBio Analyzer

Apr
Completed a round of Fundraising of NTD $97 million at $15 per share; Total of NTD $270 million paid-in capital was raised

Mar
Introduced PlexBio 100 Analyzer and PlexBio Thermo Shaker

 

Dec
Introduced ISO/GMP quality systems and certified plant

Apr
Introduced PlexBio 100 Analyzer and PlexBio Thermo Shaker

Dec
Establishment of Research Centers for Applied Proteomics

Oct
Collaborated with Cathy general Hospital to complete a clinical trial on the screening of diagnostic reagent in 150 HPV cases, which paved the way for subsequent development of IntelliPlex series using digital analyzer phase I.

Apr
Signed a contract with the Instrument Technology Research Center of the Nation Research Laboratory (NAR Lab) in July 2011 to develop digital analyzer phase I
 

Oct
Completed factory set-up registration
Establishment of HongKong Co., Limited

Jun
Establishment of HongKong Co., Limited

Dec
PlexBio Co., Ltd was established with a registered capital of $52,600,000 NT