We are thrilled to share a major milestone for Leadgene! Our independently developed and manufactured in vitro diagnostic (IVD) reagent for kidney function assessment, Leadgene® Indoxyl Sulfate (IS) ELISA, has successfully completed medical device registration with the Australian Therapeutic Goods Administration (TGA) and was officially listed on the Australian Register of Therapeutic Goods (ARTG) on July 21, 2026.
Achieving this registration marks a significant step forward in expanding our presence in the Oceania market. It provides healthcare, diagnostic, and research partners in Australia with greater convenience and confidence when evaluating, procuring, and adopting our product. Furthermore, it highlights our end-to-end integration capabilities in IVD product development, manufacturing, and international regulatory alignment.
A big thank-you to our team and partners for supporting us every step of the way! Moving forward, Leadgene Biomedical will continue to bring our proprietary innovations to the global stage. We look forward to collaborating with healthcare, testing, research, and distribution partners worldwide to expand the reach of IS testing technology and empower kidney health assessment globally!
