Leadgene Biomedical, Inc., a pioneer in innovative in vitro diagnostic (IVD) solutions, has achieved a significant milestone with its proprietary "Leadgene Indoxyl Sulfate (IS) ELISA Kit" officially approved for market release by the Health Sciences Authority (HSA) of Singapore.
This IVD certification signifies not only a crucial step into the Southeast Asian market but also a strong endorsement of the kit’s quality and technological excellence. Designed to rapidly detect levels of the protein-bound uremic toxin indoxyl sulfate, the kit aids clinicians in evaluating kidney function, contributing to early detection and precision management of chronic kidney disease (CKD) worldwide.
Indoxyl sulfate (IS) is a protein-bound uremic toxin derived from the intestinal microbial metabolism of dietary tryptophan. Under healthy renal function, IS is efficiently excreted by the kidneys. However, in patients with impaired kidney function—especially those with reduced glomerular filtration rate (GFR)—IS tends to accumulate in the body. Studies have confirmed that elevated IS levels are directly nephrotoxic, exacerbating oxidative stress, tubular damage, and fibrosis, which accelerate the progression of CKD toward end-stage renal disease (ESRD).
Moreover, elevated IS levels are strongly associated with higher overall mortality in kidney patients and an increased risk of cardiovascular disease, renal bone disorders, sarcopenia, and neurodegenerative diseases. Thus, regular monitoring of IS is clinically vital for early kidney function assessment, CKD progression prediction, and risk evaluation of related complications.
“Our mission goes beyond delivering diagnostic tools—we aim to empower clinicians and patients with the ability to anticipate and act early,” said Leadgene Biomedical Chairman Dr. Chasel Yung-Chun Chuang. Accurate measurement of IS concentration enables early detection of kidney dysfunction, allowing physicians to provide comprehensive assessments and initiate personalized treatment strategies, thereby slowing disease progression.
Featuring a world-first core technology, the product is protected by multiple international patents. It has previously obtained regulatory approvals from the Taiwan FDA (TFDA), the EU CE-IVD, and Vietnam, and was awarded the prestigious 2024 Symbol of National Quality (SNQ) certification.
Beyond regulatory achievements, the "Leadgene Indoxyl Sulfate ELISA Kit" has gained recognition from both academic and clinical sectors. It is currently in use at several leading medical institutions in Taiwan, including Taipei Medical University Hospital, National Cheng Kung University Hospital, Cardinal Tien Hospital, St. Martin De Porres Hospital, and UPL Medical Laboratory. Moreover, the kit has been cited in over six international scientific publications, underscoring its reliability and stability in research related to protein-bound uremic toxins.
