PIK3CA Mutation Detection Kit for Personalized Therapy in Ovarian Clear Cell Carcinoma Achieves Insurance Coverage, Sales to Begin July 1

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 immunology, and is engaged in the research, development, manufacturing, and sales of clinical diagnostic reagents and reagents for basic research.

In the clinical diagnostics business, the company develops and markets diagnostic tests for autoimmune diseases, cancer, and infectious diseases. As a leading domestic manufacturer in the field of autoimmune antibody diagnostics, it continues to enhance its product lineup and contribute to medical care in this area, which involves many intractable diseases. In the field of cancer diagnostics, the company develops companion diagnostics to predict drug efficacy, contributing to personalized medicine. For more information, visit https://www.mbl.co.jp/.

About Tokuyama Corporation

Since its founding in 1918, Tokuyama has specialized in inorganic chemistry and, beginning in the 1970s, expanded its business domains into organic and polymer chemistry to address societal challenges, continuously accumulating technology and developing innovative products. The company has positioned "electronics" and "health" as growth businesses and is transforming its business portfolio with in vitro diagnostics as a core component of its health segment. For more information, visit https://www.tokuyama.co.jp/.

Inquiries regarding this release

Medical & Biological Laboratories Co., Ltd.

Head Office: 2-11-8 Shibadaimon, Minato-ku, Tokyo 105-0012

Phone: 03-6684-6860 (main)

Inquiry Form: https://ivd.mbl.co.jp/diagnostics/inq/

End