Press Releases

Dec/04/2024

GBC Chemiluminescence Analyzer Secures TFDA Certification, Boosting Business Momentum

GBC (4117) announced today (4th) that it continues to deepen its focus in areas such as precision diagnostics, liquid biopsy, CDMO testing services, and P113 antimicrobial peptide drug products. These efforts aim to expand the group’s service scope and align with the trends in precision health. GBC will showcase its products, including the Chemiluminescence Analyzer (CLIA), the GBC AIO M160 fully automated nucleic acid detection system, and the CellBio Circulating Tumor Cell (CTC) detection system, at the 2024 Taiwan Healthcare+ Expo from December 5 to December 8.

Notably, the GBC CL i120 Chemiluminescence Analyzer (CLIA) under GBC has officially received special project manufacturing approval from Taiwan’s TFDA in Q4 and is concurrently progressing in its application for EU IVDR medical device certification. This development is expected to generate robust demand for diagnostic reagent products and support steady growth in GBC precision medicine business.

GBC highlighted its end-to-end operational model, encompassing research and development, manufacturing, clinical trials, and international distribution. This integrated approach strengthens its three major business groups: precision medicine, digital medical diagnostic services, and new drug and biopharmaceutical product development.

In the precision medicine segment, GBC has been actively investing in diagnostic equipment development over the past two years to offer a combined “equipment + diagnostic reagent products” sales service for hospitals, clinics, and laboratories. The GBC CL i120 Chemiluminescence Analyzer has obtained TFDA approval and is pursuing EU IVDR certification, enhancing its opportunities for domestic and international orders. The anticipated increase in equipment sales is expected to drive steady demand for diagnostic reagents, bolstering business growth.

GBC further elaborated on its Chemiluminescence Immunoassay (CLIA) technology platform, which can be used for detecting various conditions such as tumor markers, thyroid function, infectious diseases, hormones, cytokines, cardiovascular conditions, and other specialized applications. Combined with the high-throughput and low-throughput automated CLIA systems (GBC Chemiluminescence Analyzer), these platforms offer features such as high efficiency, precision, smart convenience, flexibility, and reliability. The systems boast testing speeds of 120 to 200 tests per hour, effectively addressing the high-efficiency diagnostic needs of clinical laboratories.

Additionally, GBC introduced its GBC AIO M160, a new fully automated nucleic acid detection analysis system. This molecular diagnostic platform integrates DNA/RNA extraction, amplification, and data analysis functions into a single device. The system supports up to 16 sample tests within 1-2 hours, allowing for direct processing of collected samples while minimizing the risk of cross-contamination. These attributes make it a precise and reliable solution for molecular diagnostics. GBC actively participates in prominent domestic and international biomedical exhibitions to promote its products and foster distributor partnerships.

GBC General Manager, Frank Lin, emphasized the value of precision medicine in providing accurate treatment and tailored therapies while tracking patients’ responses to treatment. He noted the immense potential in diagnostics and pharmaceuticals, particularly given cancer’s status as the leading cause of death in Taiwan. GBC CellBio Circulating Tumor Cell (CTC) detection system features high capture rates and detection precision. In collaboration with Fubon Life Insurance, the company offers “next generation myCTC circulating tumor cell blood testing” services at over 70 blood collection sites. Customers receive test reports within seven working days after sample collection. Since the service’s inception in 2021, testing cases have grown rapidly, with over 25,000 cases accumulated to date, highlighting GBC’ solid footing in precision medicine.

Looking ahead, GBC is committed to advancing its three major business groups, investing in molecular diagnostics, liquid biopsy, and cancer diagnostic technologies. The company also integrates big data and AI technologies to drive biomedical industry upgrades. Furthermore, GBC is set to enhance its resource integration with the expected launch of its AI Park Office Building in the first half of next year. The company plans to establish nine key centers, including a molecular diagnostics laboratory, innovative diagnostic instrument R&D center, precision medical diagnostics center, immune and stem cell cultivation center, protein-based drug R&D and pilot production center, and a personalized precision medicine service center, aligning with the precision health trend.

 

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