Guangzhou LBP Medicine Science & Technology Co., Ltd. has achieved a significant milestone by obtaining Class III medical device approval for its HER2 gene detection kit (fluorescence in situ hybridization method) for gastric cancer. This approval expands the kit's application from breast cancer tissue sections to include gastric adenocarcinoma tissue sections, facilitating its use in companion diagnostics for trastuzumab (Herceptin) treatment in gastric cancer. Clinical trials demonstrated 100% consistency with both comparative reagents and the original companion diagnostic tests. LBP is currently the first domestic manufacturer to receive such approval for gastric cancer HER2 detection, offering dual-platform testing through immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). This advancement enhances the company's product portfolio in tumor screening and precision diagnostics, strengthens the integration of its technical platforms, and bolsters its core competitiveness in the field.