March 23, 2026 - 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.
Product information:
[In Vitro Diagnostics]
About Medical & Biological Laboratories Co., Ltd.:
Medical & Biological Laboratories (MBL) was established in 1969 as the first antibody manufacturer in Japan, and researches, develops, manufactures, and sells reagents of in vitro diagnostics (IVD) and reagents for basic research. It has now expanded its business not only to the immunological field but also to the field of genetic diagnosis.
In the IVD business, we develop and sell IVD reagents for autoimmune diseases, cancer, infectious diseases, etc. Particularly in the field of autoantibody diagnosis, we are expanding our product lineup as a top manufacturer in Japan and contributing to medical care in this field where there are many intractable diseases. In the field of oncology, we are contributing to personalized medicine by developing companion diagnostics that predict the effects of drugs. For more information, please visit https://www.mblbio.com/e/
About Amoy Diagnostics Co., Ltd.:
Amoy Diagnostics (AmoyDx) is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit https://www.amoydiagnostics.com/
About Precision Medicine Asia Co., Ltd.:
Precision Medicine Asia (PREMIA) offer an integrated platform for the development of innovative oncology therapies and diagnostics in Asia, the fastest growing market for the pharmaceutical industry. PREMIA also manage a clinical-genomic lung cancer registry, the largest in the region, which includes more than 20,000 patients and allows an efficient patient identification process for clinical trial enrollment through participation by more than 200 hospitals in Japan, Taiwan, Malaysia and Thailand. For more information, please visit https://www.premia-inc.com/
Contact:
Medical & Biological Laboratories Co., Ltd.
Head Office: SUMITOMO FUDOSAN SHIBADAIMON NICHOME BLDG. 2-11-8 Shibadaimon, Minato-ku, Tokyo 105-0012 Japan
TEL: +81-3-6854-3613
Website inquiry form: https://ivd.mbl.co.jp/diagnostics/inq/
Amoy Diagnostics Co., Ltd.
Head Office: 39 Dingshan Road, Haicang District, Xiamen 361027, China
Email: info@amoydx.com
Precision Medicine Asia Co., Ltd.
Head Office: Level 21 Shiodome Shibarikyu Building, 1-2-3 Kaigan, Minato-ku, Tokyo 105-0022 Japan
TEL: +81-3-5403-5973
Email: info@premia-inc.com
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.
Product information:
[In Vitro Diagnostics]
| Product Name | AmoyDx® PIK3CA Mutation Detection Kit |
| Approval No.: | 30800EZX00012000 |
| Intended use: | Detection of PIK3CA gene mutations in DNA extracted from tumor tissue Used as an aid in identifying patients with ovarian clear cell carcinoma eligible for Risovalisib Mesilate Hydrate |
| Sample: | FFPE tissue in which the presence of tumor cells was confirmed |
| Testing method: | Real-time PCR |
| Package: | 24 tests/kit |
| Shelf life: | 12 months |
| Marketing Authorization Holder: | Medical & Biological Laboratories Co., Ltd. |
| Manufacturer: | Amoy Diagnostics Co., Ltd |
About Medical & Biological Laboratories Co., Ltd.:
Medical & Biological Laboratories (MBL) was established in 1969 as the first antibody manufacturer in Japan, and researches, develops, manufactures, and sells reagents of in vitro diagnostics (IVD) and reagents for basic research. It has now expanded its business not only to the immunological field but also to the field of genetic diagnosis.
In the IVD business, we develop and sell IVD reagents for autoimmune diseases, cancer, infectious diseases, etc. Particularly in the field of autoantibody diagnosis, we are expanding our product lineup as a top manufacturer in Japan and contributing to medical care in this field where there are many intractable diseases. In the field of oncology, we are contributing to personalized medicine by developing companion diagnostics that predict the effects of drugs. For more information, please visit https://www.mblbio.com/e/
About Amoy Diagnostics Co., Ltd.:
Amoy Diagnostics (AmoyDx) is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit https://www.amoydiagnostics.com/
About Precision Medicine Asia Co., Ltd.:
Precision Medicine Asia (PREMIA) offer an integrated platform for the development of innovative oncology therapies and diagnostics in Asia, the fastest growing market for the pharmaceutical industry. PREMIA also manage a clinical-genomic lung cancer registry, the largest in the region, which includes more than 20,000 patients and allows an efficient patient identification process for clinical trial enrollment through participation by more than 200 hospitals in Japan, Taiwan, Malaysia and Thailand. For more information, please visit https://www.premia-inc.com/
Contact:
Medical & Biological Laboratories Co., Ltd.
Head Office: SUMITOMO FUDOSAN SHIBADAIMON NICHOME BLDG. 2-11-8 Shibadaimon, Minato-ku, Tokyo 105-0012 Japan
TEL: +81-3-6854-3613
Website inquiry form: https://ivd.mbl.co.jp/diagnostics/inq/
Amoy Diagnostics Co., Ltd.
Head Office: 39 Dingshan Road, Haicang District, Xiamen 361027, China
Email: info@amoydx.com
Precision Medicine Asia Co., Ltd.
Head Office: Level 21 Shiodome Shibarikyu Building, 1-2-3 Kaigan, Minato-ku, Tokyo 105-0022 Japan
TEL: +81-3-5403-5973
Email: info@premia-inc.com
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