History - About LivzonDx - Zhuhai Livzon Diagnostics Inc.

2026

Full-range Product Lines, Success in Global Expansion Launched the world's first Autoimmune Diagnostics Streamline combining IFA, multiplexing, and CLIA. Expanded into mass spectrometry platform, forming a complete immuno + mass spectrometry therapeutic drug monitoring solution. Obtained market access in Russia for the HIV viral load assay. Showcased the HIV viral load testing solution at the 26th International AIDS Conference in Brazil, upon invitation from the Chinese Association of STD and AIDS Prevention and Control.

2025

Continuous Expansion, Debut of FluoroCore Alzheimer's plasma tests — Aβ42/40 and pTau-181 (CLIA) — approved and launched. Cytokines and antiphospholipid syndrome-associated autoantibodies (CLIA) approved and launched. Launched FluoroCore — AI-assisted IFA Classifier, addressing long-standing industry pain points through AI technology. HIV viral load market share in China reached 35%, ranking first among domestic products. First domestic company to receive Gates Foundation funding for HIV viral load, advancing WHO PQ.

2024

Multi-mode Luminescence, Innovative IVD Instruments & Reagents Achieved 50% market share among the Top 10 hospitals in the Fudan Hospital Ranking with the fully automated DLCM analyzer. Pioneered the first integrated dual mode system (DLCM +CLIA). Dual mode immunoassay analyzer was listed in Guangdong Provinces’ Innovative Medical and Healthcare Product Catalog.

2023

Technology Transfer & Product Iteration Completed technology transfer for TPPA and MYCO II, enabling global supply under Livzon brand. Obtained approval and launched the second-generation X-ray blood irradiators (X-RAD 6000/8000).

2022

Authoritative Certification & Import Substitution HIV viral load test underwent a large-scale authoritative evaluation by China CDC; demonstrating performance comparable to Roche and becoming the only high-throughput domestic brand in active use. Surpassed Abbott in HIV viral load testing market share, ranking second after Roche. Launched a fully integrated nucleic acid testing system — Sample-In, Result-Out. Obtained NMPA approval for the COVID-19 antigen test.

2021

Full-chain Independence, Proven Strength Established Lihe Medical in the Hengqin Guangdong-Macao In-Depth Cooperation Zone, focusing on upstream autoimmune raw materials — making Livzon one of the few companies globally with full-industry-chain self-production capability. Autoimmune diagnostics passed large-scale clinical evaluation at Peking Union Medical College Hospital's rheumatology department; with outstanding performance, defeated strong competitors and successfully won the bid.

2020

New Products Launched, Fruitful Achievements First batch of products from the three major technology platforms — Multiplex Liquid Chip, Molecular Diagnostics, and Chemiluminescence — launched successively. DLCM analysis system and Xray blood irradiator were included in the First Set of Major Technical Equipment Catalog. China's first Xray blood irradiator launched. Launched one of China's earliest approved COVID19 IgG/IgM rapid antibody tests. Received recognition from multiple overseas institutions and exported to over 40 countries.

2018

Technology Breakthroughs, Poised for Growth Completed development of the fully automated DLCM system, entering the clinical stage. The Ministry of Ecology and Environment and U.S. Department of Energy jointly launched the "Sino-US Radioactive Source Replacement Technology" research; Livzon Diagnostics stepped up and answered the call! Developed China’s first individual NAT assay for HBV, HCV, and HIV-1/2, with excellent performance demonstrated in a 100,000-case head-to-head clinical trial against Roche. Established the Suzhou R&D Center. Approved for "Postdoctoral Research Station".

2017

Relocation & Capacity Expansion, In-house Raw Material R&D Relocated from Pingdong 3rd Road to Tongchang Road, expanding R&D and production capacity. Built an in-house raw material R&D team, completing fullchain capabilities covering raw materials, reagents and instruments.

2016

From Cooperation to Independent R&D: Building Proprietary Core Technologies Established 3 core technology platforms: Digital Liquid Chip Method (DLCM) Multiplexing ,Molecular Diagnostics and Chemiluminescence. Establised an automation R&D team. Established the "Guangdong Provincial Postdoctoral Innovation Practice Base".

2014

New Product Launch, Expanding Business Model China's first rapid MP test 50% + toptier coverage, leading respiratory diagnostics.

2012

Autoimmune Layout, Exploring New Tracks Partnered with Human on immunoblot product series, entering the autoimmune diagnostics field.

2009

Crossborder Entry, Setting Sail for Irradiation Business Partnered with Huake Nuclear on γray blood irradiators, entering the blood irradiation fieldare remained above 75%.

2006

Relocation & Capacity Expansion, Leading in Segmented Tracks Relocated from Guihua North Road to Pingdong 3rd Road. Partnered with Siemens Syva TDM and became market leader with 50%+ market share. Partnered with Singapore MP on HIV confirmatory tests — sustained 75%+ market share.

2002

International Cooperation, Consolidating Market Position Partnered with Fujirebio on TPPA and MYCO II. Became one of the earliest companies in China providing respiratory pathogen testing. MYCO II became the reference method for Mycoplasma Pneumoniae testing. TPPA became the reference method for syphilis testing.

1990

International Cooperation, Consolidating Market Position Partnered with Fujirebio on TPPA and MYCO II. Became one of the earliest companies in China providing respiratory pathogen testing. MYCO II became the reference method for Mycoplasma Pneumoniae testing. TPPA became the reference method for syphilis testing.

1989

Rise at Early Stage with Group Backing Established as the first whollyowned subsidiary of Livzon Pharmaceutical Group. One of the earliest manufacturers of ELISA reagents in China, first to enter the hepatitis testing field.