Reported by Global Bio & Investment News Center
On October 28, Leadgene Biomedical announced its continued expansion into Southeast Asia. The company's Indoxyl Sulfate (IS) ELISA Kit has received regulatory approval for marketing in Singapore and Vietnam. Through its recent participation in the Singapore Society of Nephrology Annual Scientific Meeting and a product seminar in Vietnam, Leadgene has been promoting the use of IS testing in chronic kidney disease (CKD) assessment. By combining scientific exchange with local distribution partnerships, the company aims to expand the product's adoption across Southeast Asia.
Leadgene Biomedical stated that its IS ELISA Kit has received Class III in vitro diagnostic (IVD) medical device approval from the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare, and has been awarded the Symbol of National Quality (SNQ). The product has also obtained CE-IVD certification in the European Union and recently received approval from Australia's Therapeutic Goods Administration (TGA), establishing a foundation for further international market expansion.
Dr. Ping-Hsun Wu, a nephrologist at Kaohsiung Medical University Chung-Ho Memorial Hospital, recently delivered a presentation at the Singapore Society of Nephrology Annual Scientific Meeting on the role of Indoxyl Sulfate in CKD monitoring. He noted that changes in IS levels are associated with kidney disease progression and cardiovascular complications, suggesting that IS may provide complementary information beyond conventional kidney function markers.
Dr. Ping-Hsun Wu, a nephrologist at Kaohsiung Medical University Chung-Ho Memorial Hospital, noted that indoxyl sulfate, a protein-bound uremic toxin, is a silent driver accelerating kidney disease progression and triggering fatal cardiovascular complications. (Photo/Provided by Leadgene Biomedical)
Leadgene Biomedical also reported that its team visited Hanoi University of Business and Technology (HUBT) in early October to host a product seminar and scientific lecture. Titled "A Multidimensional Assessment of Kidney Function," the event highlighted the applications of IS testing in assessing renal tubular injury, CKD, and disease progression. The event attracted nearly 100 attendees, including local researchers, university faculty members, and representatives from healthcare institutions.
Leadgene Biomedical presented in Vietnam on the diverse applications of precision indoxyl sulfate testing across kidney disease assessment, disease monitoring, and clinical research. (Photo/Provided by Leadgene Biomedical)
Dr. Yung-Chun Chuang, Chairman of Leadgene Biomedical, noted that CKD prevalence exceeds 10% in both Vietnam and Taiwan. Both markets face challenges in early detection, monitoring asymptomatic disease progression, and reducing the risk of end-stage kidney disease. Leveraging its small-molecule antibody development technology, Leadgene has developed the IS ELISA kit to provide physicians with additional information for disease monitoring and risk assessment alongside conventional kidney function markers.
Looking ahead, Leadgene Biomedical plans to host a product seminar in Manila, the Philippines, in November, introducing the role of IS testing in kidney disease monitoring to local nephrologists and laboratory professionals. Through continued scientific exchange and partnerships with local distributors, the company aims to further expand its presence across Southeast Asia, the broader Asia-Pacific region, Europe, and the United States.
【Leadgene Biomedical】
Founded: 2013
Founders: Dr. Yung-Chun Chuang, Dr. Yu-Wei Cheng
Company Overview:
Leadgene Group integrates recombinant protein and antibody manufacturing, expanding across preclinical testing, automated cell line development, and healthcare services to build an end-to-end value chain from biotech R&D to practical applications.
As the parent company, Leadgene Biomedical supplies high-quality critical biological raw materials and independently developed the world's first IVD kit to support renal function assessment.
Its subsidiaries include SIDSCO, operating a TAF-accredited GLP facility specializing in diverse animal disease models; Leadgene Biosolutions, leveraging innovative microfluidics to deliver automated, high-throughput cell line development platforms; and Trustwell Pharmacy, offering comprehensive, one-stop healthcare and wellness services.
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