Development & History

From Immunological Testing to Health Management Applications

About Excelsior Bio-System Incorporation | Health Management Applications Based on Diagnostic Technology

EBS positions itself as an “Allergy Management Strategy Partner,” with long-term investment in bioimmune testing and in vitro diagnostic technologies. Starting from allergen testing, it has gradually expanded into diversified health applications for humans, dogs and cats, and livestock animals.

Since its establishment, EBS has continuously accumulated capabilities in R&D, manufacturing, quality management, and market expansion. Based on scientific diagnostic testing, it connects clinical practice, care applications, and health management needs, gradually building a development path centered on diagnostic technology.

This history has shaped EBS’s current brand foundation and allows its subsequent technology platforms, products, and service applications to be built on long-term accumulated expertise.

Brand Development Journey | From Research Foundations to Global Expansion

From its early foundation in scientific research, to the establishment of manufacturing and quality systems, and more recently the expansion into international markets, Excelsior Bio-System Incorporation has gradually built its core technological and application capabilities centered on diagnostic testing.

This journey represents not only the company’s growth in scale, but also its continued efforts to connect immunological testing, in vitro diagnostic technologies, and real-world applications. Through this approach, diagnostic results are not treated merely as isolated data points, but as an important foundation for health management and professional decision-making.

2004–2010

Research Foundations and Industry Transformation

The foundation of Excelsior Bio-System Incorporation was built upon a long-term commitment to immunological diagnostic technologies. From the company’s establishment and accumulation of R&D expertise to the later development of manufacturing and quality control infrastructure, this phase laid the groundwork for its transition from a research-focused company toward industrialized applications.

2004

Excelsior Bio-System Incorporation was established at the Industrial Technology Research Institute (ITRI) Incubation Center, initiating research and development in immunological diagnostics and related products.

2005

The company officially completed registration and gradually established its operational and R&D foundations.

2006

Development of probiotic-related technologies began, incorporating health management and supportive applications into future R&D directions.

2007

The company relocated to Neihu District, Taipei City, establishing its operations center and further integrating R&D, operations, manufacturing, and testing resources. In the same year, Mr. Chen Tso-Fan, formerly General Manager of the international animal healthcare pharmaceutical company Merial, joined the team, contributing his expertise in market development and management to support the company’s future growth.

2008

Pet allergen testing services for dogs and cats were launched, extending allergen testing applications from humans to companion animal healthcare. In the same year, the company’s immunofluorescence reagent research received recognition from the Ministry of Education’s Industry-Academia Collaboration Excellence Program, reflecting growing external recognition of its early-stage R&D capabilities.

2010

Excelsior Bio-System Incorporation further transformed into an integrated company encompassing R&D, manufacturing, quality control, and sales capabilities, while also recruiting professionals in manufacturing, quality assurance, and R&D. During the same year, the company established a GMP manufacturing facility equipped with ISO 14644-1 compliant cleanrooms, as well as dedicated R&D and quality control laboratories, laying the foundation for future in vitro diagnostic reagent manufacturing and quality management. This phase enabled Excelsior Bio-System Incorporation to gradually establish the foundational capabilities required for diagnostic product development, manufacturing, and application services beyond its early research-focused operations.

凌越生醫進一步轉型為整合研發、製造、品管與銷售能力的公司,並引進製造、品保與研發等專業人才。同年建置 GMP 工廠,配置符合 ISO 14644-1 規範之無塵室,並設立研發實驗室與品管實驗室,為後續體外診斷試劑製造與品質管理奠定基礎。
2011–2017

Professional Certifications and Quality Foundations

Following the gradual establishment of its technological and manufacturing capabilities, Excelsior Bio-System Incorporation further strengthened its quality management systems, medical device regulatory compliance, and international market entry capabilities, enabling its R&D achievements to evolve into standardized and commercially applicable diagnostic products.

2011

The company obtained its factory registration certificate as a “Manufacturer of In Vitro Diagnostic Reagents under Pharmaceutical Manufacturing,” and achieved ISO 9001:2008 certification for animal-use immunological and microbiological in vitro diagnostic reagents and functional probiotics. In the same year, the “Bio-Minsure” probiotic product received Canada Natural Product Number (NPN) certification, establishing a foundation for international market expansion.

2011

During this phase, the company underwent management restructuring, with Mr. Chen Tso-Fan assuming the position of Chairman and continuing to guide the company toward a more comprehensive medical device and biotechnology industry framework.

2012

The company implemented a medical device Good Manufacturing Practice (GMP) quality system and obtained ISO 13485 and GMP certifications, further strengthening its foundation in medical device manufacturing and quality management. In the same year, it obtained its first medical device sales license, officially becoming a fully qualified medical device company.

醫療器材許可證 免疫螢光 IgE 檢測試劑套組
2013

Centered on immunofluorescence reagents and allergen testing microarray chips, the company obtained multiple product certifications, including the European CE Mark and Taiwan E6C licenses, while also completing China Class III in vitro diagnostic medical device clinical validation and market entry.

2014

The company received the 11th National Innovation Award for its allergen testing microarray chip and was selected by the Taipei City Government as a First Investment Benchmark Enterprise. In the same year, it was also recognized as a Pioneer Incubation Enterprise by the Small and Medium Enterprise Administration of the Ministry of Economic Affairs, and received the Innovative R&D Award in the Agricultural Technology Enterprise Excellence Awards from the Council of Agriculture, Executive Yuan.

2014–2016

The company continuously obtained product certifications and import licenses in China, Thailand, Malaysia, Australia, and other regions, gradually accumulating experience in multinational regulatory compliance, market entry, and international expansion. The significance of this phase was not limited to obtaining certifications and awards, but rather the establishment of a comprehensive foundation spanning R&D, manufacturing, quality management, and market applications.

2018–2022

Business Expansion and Pandemic Response Applications

As its technological, quality, and product foundations matured, Excelsior Bio-System Incorporation further established a multi-line product and service strategy while extending its diagnostic capabilities into livestock disease detection and public health applications.

2018

The company established development strategies for three product lines focused on human, companion animal, and livestock applications, while renewing its BSI ISO 13485 certification to further strengthen its quality management system and market application foundation.

BSI ISO 13485:2016 品質管理系統認證
2019

The African Swine Fever rapid diagnostic reagent was officially launched after validation by an OIE-recognized (now WOAH) international laboratory, demonstrating the company’s technological strength in rapid animal disease diagnostics. In the same year, the allergen testing microarray chip once again received recognition through the National Innovation Award.

2020–2022

In response to the global COVID-19 pandemic, Excelsior Bio-System Incorporation rapidly leveraged its existing diagnostic platforms and development experience to develop COVID-19 testing products, becoming the first biotechnology company in Taiwan to receive special manufacturing approval from the Ministry of Health and Welfare for COVID-19 antibody rapid test reagents. The company subsequently developed antibody, antigen, and neutralizing antibody testing reagents, officially joining Taiwan’s national pandemic response team and demonstrating strong capabilities in rapid R&D and product commercialization.

新冠抗原快篩試劑 衛福部專案製造核准函
2020–2022

During the pandemic, Excelsior Bio-System Incorporation became an active participant in Taiwan’s disease prevention system through the development and supply of diagnostic products. The company also received the Bronze Award in the Medical Device Category of the Pharmaceutical Technology Research and Development Award, reflecting its accumulated expertise in pandemic response applications and in vitro diagnostic product development. This phase marked the company’s transition beyond research and manufacturing, expanding its technological capabilities into real-world applications in pandemic prevention, animal disease diagnostics, and commercial markets.

2023–Present

International Expansion and Ongoing Innovation

In recent years, Excelsior Bio-System Incorporation has continued advancing its international expansion strategy through overseas market development, international certifications, and technological innovation, bringing Taiwan’s accumulated diagnostic technologies and application experience to broader global markets.

2023–Present

The company continues expanding into overseas markets including Canada, the United States, Southeast Asia, and Northeast Asia, while also providing technical support to assist the implementation of related diagnostic applications in Malaysia’s central laboratory.

2024

The company’s “African Swine Fever Antibody Rapid Diagnostic Reagent” received international registration certification from the World Organisation for Animal Health (WOAH), representing a significant international achievement in livestock disease diagnostics.

WOAH 非洲豬瘟抗體快速診斷試劑國際認證
2025

A Canada office was established as an important milestone in the company’s overseas expansion strategy, strengthening international market connections and local operational foundations.

2026

The company obtained two patents related to rapid test reagent manufacturing tools, further strengthening its diagnostic manufacturing processes, integration of production, sales, and R&D, and technological application capabilities.

快篩試劑貼合製具專利證書 M681700快篩試劑貼合製具專利證書 M680769
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Core Research and Technology

Learn how Excelsior Bio-System Incorporation has established integrated R&D and application capabilities, from raw material preparation and antigen development to diversified diagnostic platforms 。

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Quality Certifications and Awards

Learn about Excelsior Bio-System Incorporation’s long-term achievements in quality management, medical device regulatory compliance, certifications, awards, and research accomplishments.

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Media Coverage and Events

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Products & Services

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Brand Philosophy and Mission

Learn why Excelsior Bio-System Incorporation continues to invest in long-term health management and care support through its commitment to diagnostic testing.

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