Month: August 2026

GBC CL i120 Earns EU IVDR Certification, Marking New Milestone in Global CLIA Expansion

Posted on by catherine

Hsinchu, Taiwan – August 25, 2026

GBC, a precision medicine company (TWSE: 4117), today announced that its GBC CL i120 Fully Automated Chemiluminescence Immunoassay System has recently obtained European Union In Vitro Diagnostic Medical Devices Regulation (IVDR) certification, making it the first CLIA system in GBC’s portfolio to complete the relevant EU IVDR registration process. GBC stated that the IVDR certification of the GBC CL i120 marks important progress in the regulatory readiness, product quality, and international market expansion of its next-generation automated immunoassay platform. It also establishes a solid foundation for the overseas expansion of related CLIA instruments and reagents, supporting future business growth and operational momentum.

GBC noted that the CL i120 Fully Automated Chemiluminescence Immunoassay System is one of the Group’s key platforms for developing its next-generation IVD portfolio. Designed to address the demand for automation, efficiency, and consistent testing quality among small- and medium-sized healthcare facilities, laboratories, and regional medical institutions, the platform is supported by a comprehensive range of instruments and chemiluminescence reagents covering tumor markers, thyroid function, hormones, infectious diseases, and other immunoassay applications. To date, 13 CLIA reagents have obtained medical device approvals from Taiwan’s TFDA, highlighting GBC’s continued progress in the development of its CLIA instruments and reagents, as well as its regulatory strategy. As additional reagent products receive regulatory approvals, the broader menu is expected to expand the platform’s application scope and strengthen reagent utilization following instrument placement.

According to the latest report from market research firm MMR Statistics, the global IVD market is projected to grow from US$87.2 billion in 2025 to US$135.59 billion by 2032, representing a compound annual growth rate (CAGR) of 6.51%. Growth is driven by the increasing burden of chronic and infectious diseases, rising demand for early and precise testing, the expansion of preventive healthcare programs, and growing adoption of molecular diagnostics, point-of-care testing, automation, and AI-assisted diagnostic technologies.

GBC stated that it sees continued growth opportunities in the global IVD market as testing increasingly moves toward automation, precision, and real-time results. Healthcare institutions and laboratories are placing greater emphasis on testing efficiency, result consistency, and comprehensive test menus. With high sensitivity, a high degree of automation, and strong scalability across test applications, chemiluminescence immunoassay (CLIA) technology has become an important platform for immunoassay testing. By combining its CLIA platform with comprehensive reagent development capabilities, GBC aims to strengthen its product competitiveness in the IVD market, while increasing the visibility of its GBC brand and creating further opportunities for international business expansion.

GBC continues to steadily expand its precision medicine business, with its CLIA chemiluminescence immunoassay systems regarded as one of the key growth drivers. Approximately 11 CLIA systems have been placed at healthcare institutions and laboratories in Taiwan to date. Through instrument placements, reagent adoption, and customer feedback, GBC is gradually building its application experience and market service capabilities. GBC emphasized that its CLIA strategy goes beyond the sales of individual instruments. By integrating platform instruments, testing reagents and consumables, after-sales services, and application support, the company aims to establish long-term partnerships and drive the gradual expansion of reagent utilization.

Following the CL i120’s EU IVDR certification, GBC expects to further strengthen the confidence of overseas distributors and healthcare channels in the product’s regulatory compliance and quality consistency, creating additional opportunities for market entry. The company is also actively exploring opportunities in the Middle East and Southeast Asia. Based on the regulatory requirements and testing needs of individual markets, GBC will gradually introduce its instruments, reagents, and consumables, expanding the commercialization opportunities of its CLIA platform overseas and supporting future business growth.

Media Contacts

GBC
Frank Lin, General Manager
Tel: +886-3-577-9221
frank.lin@gbc.com.tw

IR Trust
Sandy Cheng, Vice President
Tel: +886-2-2585-5701 / +886-931-914-467
sandy@ir-trust.tw

About GBC

GBC (TWSE: 4117), founded in June 1984, has established an integrated value chain covering research, development, manufacturing, sales, and testing services. For more than 40 years, GBC has remained committed to creating better and more affordable in vitro diagnostic (IVD) products that are accessible to everyone. Its product portfolio covers infectious diseases, respiratory infections, blood virology, fertility and sexual health, oncology, human genetics, and emerging infectious diseases. GBC’s IVD products and instruments have become trusted solutions for healthcare professionals, laboratory technicians, blood banks, and consumers, with products sold in more than 40 countries worldwide.

Building on its expertise in testing, GBC is expanding toward precision medicine, preventive healthcare, and broader health applications by integrating testing technologies with complementary approaches. Its businesses span precision IVD reagents, Digital Medical Laboratory (DML) services, and the commercialization of antimicrobial peptide (AMP) pharmaceutical and healthcare products, supporting the company’s long-term development in the broader healthcare market.

Official Website: GBC Official Website

Forward-Looking Statements

This document and the related information released concurrently contain forward-looking statements. Except for statements concerning facts that have already occurred, all statements regarding GBC’s future business operations, potential events, and prospects—including, but not limited to, forecasts, targets, estimates, and operating plans—are forward-looking statements. Such statements are subject to various factors and uncertainties that may cause actual results to differ materially from those expressed or implied. These factors include, but are not limited to, price fluctuations, actual demand, exchange rate movements, market share, market competition, changes in legal, financial, and regulatory frameworks, international economic and financial market conditions, political risks, cost estimates, and other risks and variables beyond GBC’s control. These forward-looking statements are based on current expectations and assessments, and GBC assumes no obligation to update them in the future.

GBC July Revenue Reaches NT$24.63 Million, Up 57.82% YoY

Posted on by catherine

Growing CLIA System Installations to Drive Reagent and Consumables Revenue, Supporting Long-Term Business Growth

Hsinchu, Taiwan — August 10, 2026

General Biologicals Corporation (GBC, hereinafter referred to as “GBC”; TWSE: 4117), a precision healthcare solutions provider, today announced consolidated revenue of NT$24.63 million for July 2026, representing a 57.82% year-on-year increase. The growth was primarily driven by continued growth in orders for its precision healthcare testing business. Some overseas reagent orders have been rescheduled by customers and will be recognized progressively from August. This adjustment does not affect overall order momentum or the Company’s full-year operating outlook. Consolidated revenue for January through July 2026 totaled NT$179.85 million, up 41.77% from the same period last year.

GBC stated that its CLIA Chemiluminescence Immunoassay System is expected to be one of the key growth drivers of its precision healthcare business. The CLIA platform has gradually been introduced into healthcare institutions and laboratories in Taiwan. Its business model leverages instrument placements to generate continued demand for reagents and consumables. Each additional system installed is expected to create long-term testing demand and recurring revenue opportunities. Currently, approximately 11 systems have been installed at healthcare institutions and laboratories in Taiwan. As the installed base continues to expand, the commercial benefits of the CLIA platform are expected to become increasingly evident.

GBC further stated that its CLIA Chemiluminescence Immunoassay System offers high efficiency, high throughput, and high sensitivity, supporting a wide range of testing applications, including tumor markers, thyroid function, hormones, and infectious diseases. More than 10 chemiluminescence reagent assays have obtained TFDA medical device approvals, while the Company continues to develop additional reagent products and pursue regulatory certifications.

As the medical testing market gradually shifts from individual testing toward automated and platform-based solutions and long-term health management, demand for automated testing systems, reagents, and consumables from healthcare institutions and laboratories is also increasing. This trend is expected to support GBC’s long-term growth through its “system placement + reagents and consumables” business model.

Looking ahead to the third quarter of 2026, GBC will focus on its development strategy of “proprietary instrument development + reagents and consumables + testing services + overseas regional distribution partnerships.” The Company will accelerate regulatory approvals and overseas market expansion for its CLIA Chemiluminescence Immunoassay System. In addition, continued sales growth from “oh care,” the proprietary brand of GBC’s subsidiary Gene Research Laboratories Co., Ltd. (GRL), is expected to contribute positively to future operating performance.

For the second half of 2026, GBC will continue to expand CLIA system installations, broaden its chemiluminescence reagent portfolio, increase utilization among existing healthcare institutions, and accelerate overseas market expansion. These efforts are expected to progressively enhance the commercial value of the CLIA platform and lay a solid foundation for future business growth.

In addition, continued growth in sales of “oh care,” together with ongoing development in AI-assisted interpretation, digital pathology, and precision healthcare solutions, will enable GBC to further strengthen its integrated precision healthcare offerings and long-term competitive advantages, supporting sustainable business growth.

GBC Consolidated Revenue Summary for July 2026

Unit: NT$ thousand; %

Period20262025YoY %
July24,62515,60357.82
January–July179,845126,85641.77

Media Contacts

General Biologicals Corporation (GBC)
M. D. Lin, General Manager
Tel: +886-3-577-9221
frank.lin@gbc.com.tw

IR Trust
Sandy Cheng, Vice President
Tel: +886-2-2585-5701 / +886-931-914-467
sandy@ir-trust.tw

About GBC

General Biologicals Corporation (GBC; TWSE: 4117) was founded in June 1984 and has established an integrated value chain covering research, development, manufacturing, sales, and testing services. For more than 40 years, GBC has remained committed to its goal of creating better and more affordable in-vitro diagnostic (IVD) products that are accessible to everyone.

Its product portfolio covers infectious diseases, respiratory infections, blood virology, fertility and sexual health, oncology, human genetics, and emerging infectious diseases. GBC’s IVD products and instruments have become trusted solutions for healthcare professionals, laboratory technicians, blood banks, and consumers worldwide, with products currently sold in more than 40 countries.

Building on its expertise in testing, GBC is committed to integrating testing with other healthcare approaches and expanding into precision healthcare, preventive healthcare, and broader health management. Its business areas include precision IVD reagents, Digital Medical Laboratory (DML) services, antimicrobial peptide (AMP) pharmaceuticals, and healthcare product commercialization. Through a diversified business model, GBC is building a long-term presence in the broader healthcare sector.

GBC Official Website: https://www.gbc.com.tw/tw/home/

Disclaimer

This document and the related information released concurrently contain forward-looking statements. Except for statements relating to facts that have already occurred, all statements concerning GBC’s future business operations, potential events, and prospects, including but not limited to forecasts, targets, estimates, and operating plans, constitute forward-looking statements.

Forward-looking statements are subject to various factors and uncertainties that may cause actual results to differ materially from those expressed or implied herein. These factors include, but are not limited to, price fluctuations, actual demand, exchange-rate movements, market share, market competition, changes in legal, financial, and regulatory frameworks, international economic and financial market conditions, political risks, cost estimates, and other risks and variables beyond the Company’s control.

These forward-looking statements are based on current expectations and assessments. The Company assumes no obligation to update or revise such statements in the future.