Ed Bio: Self-developed gene mutation test kit approved in Japan.

Edenbio announced that the self-developed product, the AmoyDx PIK3CA Gene Mutation Detection Kit, has recently been approved for listing by the Japanese Ministry of Health, Labor and Welfare. This product is used to detect the PIK3CA gene mutation status in patients with ovarian clear cell carcinoma, as a companion diagnostic test for the drug rucaparib. The product has accurate detection results, high success rate, stable performance, requires a small sample size, and produces reports quickly. This approval further enriches the company's tumor companion diagnostic product line, enhances the company's competitiveness in international markets, improves the company's market expansion capabilities, and will have a positive impact on the company's future development.