Medical & Biological Laboratories Co., Ltd. (President and CEO: Hiroki Ito), a group company within the Life Science Division of Tokuyama Corporation (President and CEO: Tomohiro Inoue), announces that it has received insurance coverage approval effective May 1, 2026, for the AmoyDx® PIK3CA Mutation Detection Kit (hereinafter, "the kit"), a diagnostic reagent for detecting PIK3CA gene mutations, which received manufacturing and marketing approval on March 5, 2026. With this approval, sales of the kit will commence on July 1, 2026. The kit is a companion diagnostic for the novel molecular-targeted anticancer drug Hitzexin® Tablets 10 mg (generic name: serabelisib mesylate monohydrate). With the inclusion of this kit in the insurance reimbursement system, personalized medicine based on the presence or absence of PIK3CA gene mutations in patients with ovarian clear cell carcinoma will now be available under Japan's public health insurance. Product Information [In Vitro Diagnostic Medicinal Product] Product Name: AmoyDx® PIK3CA Mutation Detection Kit Approval Number: 30800EZX00012000 Intended Use: Detection of PIK3CA gene mutations in DNA extracted from cancer tissue (used as an aid in determining patient eligibility for treatment with serabelisib mesylate monohydrate for ovarian clear cell carcinoma) Test Specimen: FFPE tissue with confirmed presence of tumor cells Measurement Principle: Real-time PCR method Insurance Points: 5,000 points D004-2 Malignant tumor tissue test 1 Malignant tumor gene test Ro Complex procedures Co PIK3CA gene test for ovarian clear cell carcinoma (real-time PCR method) Packaging Unit: 24 tests Shelf Life: 12 months Marketing Authorization Holder: Medical & Biological Laboratories Co., Ltd. Manufacturer: Amoy Diagnostics Co., Ltd About Medical & Biological Laboratories Co., Ltd. Established in 1969 as Japan's first antibody manufacturer, the company has since expanded its business into the field of genetic diagnostics, in addition to immunolo