AmoyDx® PIK3CA Mutation Detection Kit Approved as a Companion Diagnostic for Risovalisib in Japan

Original from: AmoyDx

Amoy Diagnostics Co., Ltd., Medical ＆ Biological Laboratories Co., Ltd., a group company of Tokuyama Corporation, and Precision Medicine Asia Co., Ltd. today announced that MBL received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) on March 5, 2026 for the AmoyDx® PIK3CA Mutation Detection Kit in Japan. The approval in Japan marks an important milestone achieved through the close collaboration of MBL, AmoyDx and PREMIA.

This kit was developed as a companion diagnostic for the PI3Kα (phosphatidylinositol 3-kinase alpha) inhibitor, Risovalisib (Risovalisib Mesilate Hydrate). The AmoyDx® PIK3CA Mutation Detection Kit is used to detect the presence or absence of PIK3CA gene mutations in patients with ovarian clear cell carcinoma (OCCC). It is expected to support personalized medicine by helping identify patients who may benefit from targeted therapy.

Risovalisib is developed by Haihe Biopharma Co., Ltd.. In Japan, Haihe Biopharma K.K., a wholly owned affiliate of Haihe, received approval from the Japanese MHLW on March 23, 2026 for the approved indication of "advanced or recurrent ovarian clear cell carcinoma harboring PIK3CA gene mutations that has progressed after chemotherapy." and Taiho Pharmaceutical Co., Ltd. will be responsible for providing medical information and managing the sales of Risovalisib.

Source: AmoyDx® PIK3CA Mutation Detection Kit Approved as a Companion Diagnostic for Risovalisib in Japan