"World Kidney Day" Marks a Pivotal Advance in Taiwan's Kidney Disease Treatment
Innovative Patented In Vitro Diagnostics Receives Market Approval


Annually observed on the second Thursday of March, "World Kidney Day" was established in 2006 by the International Society of Nephrology and the International Federation of Kidney Foundations to enhance global awareness of chronic kidney disease and advocate for its early detection and prevention. This year, the day holds added significance for Leadgene Biomedical, a firm dedicated to pioneering uremic toxin detection. Their groundbreaking product, the "Leadgene Indoxyl Sulfate (IS) ELISA Kit," a cutting-edge protein-bound uremic toxin detection kit, has successfully attained approval from the Taiwan Food and Drug Administration (TFDA) as a third-class In vitro diagnostic (IVDs) (MOHW-MD-No. 007625). This innovation marks the first globally patented indoxyl sulfate IVD, set to revolutionize testing by slashing time and costs, boosting efficiency, introducing novel clinical diagnostic avenues, and aiding kidney disease patients across Taiwan and beyond.


World Health Organization data from 2020 reveals that kidney diseases escalated from the 13th to the 10th leading cause of death globally between 2000 and 2019, with fatalities surging from 810,000 to 1.3 million. Research published by the authoritative journal The Lancet Regional Health in June 2022 indicates that 9.1% to 13.4% of the worldwide populace (roughly 700 million to 1 billion individuals) endures chronic kidney disease, underscoring a critical health issue in today's world.


Yung-Chun Chuang, Chairman of Leadgene Biomedical, emphasizes that indoxyl sulfate, a protein-bound uremic toxin, is confirmed to inflict damage on kidneys, the heart, and other vital organs, thus serving not merely as a risk factor for kidney disease but also as an indicator of its progression. While traditional kidney function evaluations rely on analyses like blood tests, proteinuria, and glomerular filtration rates, the prevalent clinical neglect in detecting protein-bound uremic toxins hinders comprehensive disease assessment. The "Leadgene Indoxyl Sulfate (IS) ELISA Kit" is strategically designed to prevent patients in sub-optimal health from overlooking their critical treatment phase for chronic kidney disease, aiding in the monitoring and management of the therapeutic journey to slow disease advancement, ease clinical hurdles, and boost renal health and well-being.


The 2024 "World Kidney Day" signifies a landmark moment in the annals of Taiwan's kidney disease treatment, highlighted by the debut of the "Leadgene Indoxyl Sulfate (IS) ELISA Kit." Chairman Chuang envisions the IVD’s introduction as a means to curb extensive healthcare costs and furnish medical facilities with enhanced, user-friendly kidney function metrics, thereby securing the optimal therapeutic timeframe for kidney disease, expediting patient recovery, and fostering overall health progression.