MEBGEN BRAF Kit Receives MHLW Approval as Companion Diagnostic for Use with Patients with Melanoma

Tokyo, Japan - August 1, 2022 - Medical and Biological Laboratories Co., Ltd. (President & CEO: Kimimasa Yamada, “MBL”), a JSR Life Sciences Company, announced that MEBGEN™ BRAF Kit, an in vitro diagnostic reagent, was approved for detection of BRAF gene mutations (V600E or V600K) by the Ministry of Health, Labour and Welfare (MHLW) for production and marketing in Japan on July 7, 2022.


MEBGEN™ BRAF Kit was developed as a companion diagnostic for multiple anti-cancer agents in melanoma. The MEBGEN BRAF Kit is expected to be an important clinical diagnostic in guiding personalized medicine for patients with melanoma.


Product Information:

Product Name: MEBGEN™ BRAF Kit

Approval No.: 30400EZX00054000

Purpose of use: Detection of BRAF gene mutations (V600E or V600K) in DNA extracted from cancer tissue

Used as an aid in identifying melanoma patients eligible for treatment with the following agents:

・    Combined administration of dabrafenib mesilate and trametinib dimethyl sulfoxide

・    Combined administration of encorafenib and binimetinib

Testing method: PCR-rSSO

Package size: 48 tests/ kit

Shelf life: 12 months



Medical and Biological Laboratories Co., Ltd. Molecular Diagnostics Business Planning Department

Head Quarters: SUMITOMO FUDOSAN SHIBADAIMON NICHOME BLDG. 2-11-8 Shibadaimon, Minato-ku, Tokyo 105-0012 Japan

Tel: +81-3-6684-6860

Contact form:


About Medical and Biological Laboratories Co., Ltd.

MBL was established in 1969 as the first antibody manufacturer in Japan, and researches, develops, manufactures, and sells reagents of in vitro diagnostics and reagents for basic research. MBL has now expanded its business not only to the immunological field but also to the field of genetic diagnosis. In the field of oncology, MBL is contributing to personalized medicine by developing companion diagnostics. For more information, please visit

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