Reported by GlobalBio & Investment News Center
Leadgene Biomedical and Standard Biotechnology & Pharmaceutical recently showcased their chronic kidney disease (CKD) diagnostic and care solutions at the Spring Academic Conference of the Taiwan Society of Nephrology (TSN). The exhibition featured the Leadgene® Indoxyl Sulfate (IS) ELISA Kit and Renobiome functional probiotics. Leadgene Biomedical highlighted that the core of their solution focuses on the precision detection of protein-bound uremic toxins combined with nutritional probiotic support, serving as a reference for Gut-Kidney Axis care. However, the companies emphasized that clinical application of these products should be evaluated by physicians based on individual patient conditions.
The Rise of Gut-Kidney Axis Care
Leadgene Biomedical noted that the global prevalence of CKD ranges from approximately 9.5% to 14.2%, with an estimated 788 million patients worldwide as of 2023. As CKD care increasingly explores mechanisms related to the gut-kidney axis, the screening and management of Protein-Bound Uremic Toxins (PBUTs) has become a primary focus in clinical research.
During the conference, the two companies presented a comprehensive strategy ranging from screening to management. Prof. Fang Teh-Chao, a Professor of Nephrology at Taipei Medical University, pointed out that an imbalance in the gut-kidney axis is closely linked to CKD progression. Gut dysbiosis can drive the production of PBUTs, particularly Indoxyl Sulfate (IS) and p-Cresyl Sulfate (PCS). He mentioned that precision testing for IS, when paired with traditional kidney function indicators, allows for a more comprehensive assessment of a patient's risk of renal decline.
At the 2025 Asian Pacific Congress of Nephrology (APCN), Professor Fang Teh-Chao analyzed the gut-kidney axis mechanism, highlighting that precision testing of "Indoxyl Sulfate" is key to monitoring patient health. (Photo/Provided by Leadgene Biomedical)
The Impact of Uremic Toxins
Prof. Fang explained that CKD patients often face a vicious cycle between gut dysbiosis and deteriorating kidney function. When the intestinal flora is imbalanced, the integrity of the intestinal wall (tight junctions) may be compromised. This allows uremic toxin precursors—produced by gut bacteria breaking down amino acids—to enter the bloodstream more easily. Once metabolized by the liver into PBUTs, they trigger systemic inflammation.
Among these, Indoxyl Sulfate (IS) is considered a critical PBUT. It is associated with renal cell apoptosis and fibrosis, cardiovascular, skeletal, and neurotoxicity.
Because over 90% of IS in the blood binds to albumin, it is difficult to remove effectively through conventional hemodialysis (artificial kidneys). Clinical observations show that IS levels may begin to rise as early as CKD Stage 3. Prof. Fang urged patients to consult nephrologists for testing and management rather than relying on exaggerated advertisements for drugs or health supplements.
Leadgene and Standard Biotechnology & Pharmaceutical present precision PBUT diagnostics and probiotic solutions at the TSN Spring Conference. (Photo/Provided by Leadgene Biomedical)
Advancing Precision Diagnostics
Dr. Yung-Chun Chuang, Chairman of Leadgene Biomedical, stated that precision PBUT testing serves as a vital tool for both doctors and patients to identify risk changes early. Prof. Fang added that integrating reliable testing into standard care protocols provides stable data for clinical practice, assisting in early risk assessment and strategy adjustment.
Leadgene Biomedical noted that their Indoxyl Sulfate (IS) testing significantly reduces the time and complexity compared to traditional mass spectrometry (LC-MS) methods. Key advantages include:
- High-throughput efficiency for kidney function assessment and treatment tracking.
- Regulatory Approval: Certified as a Class III In Vitro Diagnostic (IVD) by the Taiwan FDA (TFDA).
- Global Reach: Marketed in the EU, Singapore, and Vietnam.
- Clinical Adoption: Currently utilized in major institutions including TMU Hospital, Tri-Service General Hospital, KMU Hospital, NCKU Hospital, and Chi Mei Medical Center.
The Leadgene Indoxyl Sulfate (IS) ELISA Kit is a world-first, ushering in a new era of precision diagnostics for kidney disease. (Photo/Provided by Leadgene Biomedical)
