Leveraging its proprietary technology, Leadgene Biomedical has successfully navigated complex technical hurdles to develop highly specific antibodies against small molecules, resulting in patented antibodies tailored for this purpose. This breakthrough has enabled the company to independently produce a full spectrum of products, from raw materials to finished applications.
The "Leadgene Indoxyl Sulfate (IS) ELISA Kit" has been officially certified by the Taiwan Food and Drug Administration (TFDA) as a Class III in vitro diagnostic (IVD) device (MOHW-MD-No. 007625). This marks a global first and a pioneering achievement in Taiwan, promising to revolutionize clinical testing with a new solution for the prevention and management of kidney diseases. Aimed at reducing healthcare expenses and enhancing public health, Leadgene is preparing to distribute this innovative solution throughout Taiwan's leading medical centers, hospitals, clinics, and labs.
The "Leadgene Indoxyl Sulfate (IS) ELISA Kit" has been officially certified by the Taiwan Food and Drug Administration (TFDA) as a Class III in vitro diagnostic (IVD) device (MOHW-MD-No. 007625). (Image shown is a product schematic.)
The "Leadgene Indoxyl Sulfate (IS) ELISA Kit" has overcome significant technical challenges, obtaining European Union CE-IVD certification, and acquiring patents across several countries, including Taiwan, Japan, the United States, and China. The kit is currently seeking registration in the Asia-Pacific region, including Singapore and Vietnam. Following its TFDA approval, the medical community has highly anticipated its impact.
Leadgene Biomedical is a pioneer in the innovation and production of protein and antibody. Leveraging its core technologies in antibody and protein development, production, and application, the company offers stable, high-quality biological materials, detection reagents, and customized services.These contributions enhance the dynamism of Taiwan's biotechnology sector, diminish reliance on imported materials, encourage collaboration within the industry, and elevate Taiwanese products to a global audience.
The 2022 Kidney Disease in Taiwan Annual Report highlights the critical need for innovation: more than 80,000 people in Taiwan were receiving dialysis in 2020, equating to 3,771 individuals per million undergoing long-term treatment. End-stage renal disease accounted for approximately 9.2% of total National Health Insurance expenditures. Early detection and monitoring of chronic kidney disease are critical, given the subtle onset of symptoms and the challenge of assessing treatment effectiveness. Indoxyl Sulfate (IS) ELISA Kit is designed to tackle these clinical hurdles, aiming to improve kidney health and patient outcomes.
Chasel Yung-Chun Chuang, the chairman of Leadgene Biomedical, is optimistic about the Indoxyl Sulfate (IS) ELISA Kit's potential to lower long-term testing expenses, deliver more precise kidney function insights, and leverage the crucial treatment window for kidney disease. He looks forward to ongoing technological progress, positioning Taiwan for international acclaim through pioneering detection reagents, antibodies, and recombinant protein technologies, and broadening its global market footprint.
