Recently, Leadgene Biomedical secured approval from the Industrial Development Bureau of the Ministry of Economic Affairs. This approval acknowledges that the company's research and manufacturing of the “Indoxyl Sulfate (IS) ELISA Kit” comply with the standards set by Article 4, Paragraph 1, Subparagraph 2, Item 1 of the 'Biotech and New Pharmaceutical Development Act'. Consequently, Leadgene has earned recognition as a biotech and pharmaceutical company, positioning it to qualify for future investment deductions and tax incentives.


In Taiwan, the prevalence of individuals requiring kidney dialysis remains alarmingly high year after year. Conditions such as nephritis, nephrotic syndrome, and other kidney diseases consistently feature among the top ten causes of mortality in the nation. Furthermore, they are also the leading contributors to the most financially draining chronic diseases. Both domestic and international foundational and clinical studies have corroborated the critical role that protein-bound small molecule uremic toxins, especially indoxyl sulfate (a Type III uremic toxin), play in chronic kidney disease. This compound is not only pivotal for the diagnosis and tracking of chronic kidney disease progression but also significantly influences its complications. The predominant clinical testing method currently in use is liquid chromatography-tandem mass spectrometry (LC-MS/MS). However, its high cost and complexity stand as considerable hindrances to its broader adoption.


Deeply entrenched in the protein and antibody reagent domain, Leadgene Biomedical's pioneering Indoxyl Sulfate (IS) ELISA Kit is the market's first in-vitro diagnostics for detecting protein-bound uremic toxins. This innovation presents a viable alternative to the pricier and less user-friendly LC-MS/MS, facilitating a swift, high-throughput method for identifying the uremic toxin, indoxyl sulfate, in patients. Consequently, it enriches the pool of renal function data available to healthcare professionals and patients alike, promoting timely and precise treatments. Its potential applications span clinical research, kidney disease screening, disease progression tracking, and therapeutic evaluation.


Gaining approval under the 'Biotech and New Pharmaceutical Development Act' stands as a testament to Leadgene Biomedical's formidable R&D prowess. Looking ahead, the company aims to capitalize on this accolade by fostering connections throughout the biotech industry, from raw material providers to end-product distributors. With a keen eye on the in-vitro diagnostic reagent market, Leadgene Biomedical aspires to champion Taiwan's biotech and pharmaceutical sectors and spotlight the nation's notable contributions in the biomedical realm on the global stage.