General Biologicals announced that its chemiluminescence immunoassay (CLIA) technology platform is achieving successive milestones. Following the approval of its fully automated chemiluminescence immunoassay analyzer by Taiwan’s Food and Drug Administration (TFDA) for special medical device manufacturing and licensing, the company has now obtained five TFDA medical device licenses for CLIA reagents. An additional 20 reagent applications are currently under review. Several hospitals have already begun testing, and collaborations have been launched with three clinical laboratories in Taiwan, while discussions are ongoing with other hospitals and labs, helping to expand momentum in the precision medicine sector.

In addition, General Biologicals’ GBC AIO fully automated integrated diagnostic system flexibly combines DNA/RNA nucleic acid extraction, amplification, and data analysis into a single molecular diagnostics platform. The system can simultaneously process up to 16 samples within 1–2 hours, supporting both sample collection and direct loading from original tubes. The company has already received orders for the AIO system and recently passed the QMS manufacturing expansion review, with the potential to secure TFDA special manufacturing approval in the second half of the year, paving the way for broader domestic and international market expansion.

General Biologicals noted that its first-half performance benefited from strong demand for ELISA antibody reagent orders and stable medical testing services. Sales were further boosted by the company’s own brand oh care through both offline and online distribution channels in Taiwan and the U.S.

Looking to the second half, growth is expected to be driven by three pillars: expanding the CLIA platform business, accelerating AIO system orders, and collaborating with insurance channels to introduce testing services. Overall, performance is anticipated to surpass that of the first half.

To strengthen its position in precision medicine, General Biologicals will also partner with Fubon Insurance to launch innovative cancer risk testing insurance products. These will incorporate the company’s circulating tumor cell (myCTC) testing, thyroid function and thyroid cancer testing, as well as comprehensive liver health testing covering liver cancer, hepatitis, and fibrosis. Several new insurance products are scheduled for launch in the second half of the year, enhancing market penetration in precision healthcare.

Resource: 普生三箭齊發 多項化學發光試劑取得TFDA認證