Autobio Diagnostics

Autobio Diagnostics stands as one of China’s largest in vitro diagnostics (IVD) companies, providing broad solutions for clinical laboratories worldwide. Listed on the Shanghai Stock Exchange in September 2016 as the first IVD manufacturer to achieve main board listing in China, the company has built an integrated portfolio spanning immunoassay, microbiology, biochemistry, molecular diagnostics, and laboratory automation systems.

Company Overview

Founded in 1998 in Zhengzhou, Henan Province, Autobio has evolved from a regional diagnostics supplier into a global IVD enterprise with products exported to over 80 countries. The company operates from a 251-acre industrial park featuring over 720,000 square meters of facilities, including R&D centers, manufacturing plants, and China’s first Laboratory Medicine Museum.

Autobio holds over 850 product registration certificates with more than 1,700 patents. The company has been designated as a National Enterprise Technology Center and hosts the National Engineering Research Center for Emerging and Re-emerging Infectious Disease Detection. In 2024, the company reported revenue of CNY 4.47 billion.

Core Products

Microbiology Detection Systems

The Autof ms1000 automated mass spectrometry microbial identification system represents Autobio’s flagship microbiology product. Launched in 2018 with CE-IVD certification, the system achieves species-level identification in 0.1 seconds with 98.9% accuracy across a database of over 3,000 microbial species. Clinical studies published in BMC Microbiology demonstrated performance comparable to the Bruker Biotyper system.

Supporting products include the BC60/BC120 Plus blood culture systems and AutoMic-i600 automated identification and antibiotic susceptibility testing analyzer, providing end-to-end microbiology laboratory workflows.

Immunoassay Platforms

The AutoLumo series chemiluminescence immunoassay (CLIA) analyzers form the core of Autobio’s immunoassay business. The AutoLumo A6000/A6200 series achieves throughput of 600 tests per hour with sensitivity at the femtogram per milliliter level. The platform uses magnetic particle acridinium ester technology and supports over 150 reagent types covering tumor markers, infectious diseases, thyroid function, and autoimmune disorders.

Laboratory Automation

The AutoLas X-1 series total laboratory automation (TLA) system integrates biochemistry, immunoassay, and hematology analyzers with sample pre- and post-processing modules. Capable of processing over 5,000 tubes daily, the system received the German iF Design Award in 2023. The compact AutoLas B-1 Star series targets small to medium laboratories requiring space-efficient automation solutions.

Molecular Diagnostics

AutoMolec 3000 and AutoMolec 1600 systems provide automated nucleic acid purification and real-time PCR analysis with random access capability. The Autof Gene nucleic acid mass spectrometry platform received NMPA registration for genotyping applications.

Technology and Innovation

Autobio maintains reference laboratories in Zhengzhou and Beijing, both accredited by CNAS and recognized as JCTLM Stakeholder Members. These facilities operate 52 reference measurement procedures across enzymes, hormones, electrolytes, and proteins, with 24 procedures receiving CNAS accreditation.

Strategic acquisitions have strengthened the product portfolio. The 2016-2020 period saw acquisition of Biotech’s biochemistry line and Toshiba’s biochemical analyzer business, establishing the integrated “immunoassay + biochemistry + microbiology” platform. In 2019, Autobio partnered with Finland’s Mobidiag to establish Automobi Diagnostics, a joint venture focused on syndromic molecular diagnostics for the China market.

Market Presence

Autobio products serve hospitals across China and in over 80 countries internationally. The company’s microbiology segment has achieved strong growth, with the Autof ms1000 ranking first in growth rate among domestic MALDI-TOF systems. In the 2024 national volume-based procurement for biochemistry and immunoassay products, Autobio was among the companies winning the most categories.

The 326 IVDR CE-certified products enable market access across European Union member states, while select products including the Autof ms1000 have received FDA clearance for the United States market.

Key Milestones

• 1998: Company founded in Zhengzhou
• 2016: Listed on Shanghai Stock Exchange main board (603658.SH)
• 2018: Launched Autof ms1000 with CE-IVD certification
• 2019: Established Automobi joint venture with Mobidiag
• 2023: AutoLas X-1 receives German iF Design Award
• 2024: Revenue reaches CNY 4.47 billion; 326 IVDR CE certificates achieved
• 2025: AutoChem B2000 series wins German iF Design Award

Frequently Asked Questions

What is Autobio Diagnostics known for?

Autobio is recognized as a leading Chinese IVD company with broad capabilities in immunoassay, microbiology, biochemistry, and molecular diagnostics. The company is particularly noted for its Autof ms1000 mass spectrometry system and AutoLumo chemiluminescence analyzers.

Is Autobio Diagnostics publicly traded?

Yes, Autobio trades on the Shanghai Stock Exchange under stock code 603658.SH. It became the first IVD manufacturer to list on China’s main board in September 2016.

Does Autobio have international regulatory approvals?

Autobio holds over 326 IVDR CE certificates covering immunological, microbiological, and molecular products for European market access. The Autof ms1000 mass spectrometry system has received FDA clearance for the United States.