[PRESS RELEASE]MEBGEN™ BRAF 2 Kit Receives MHLW Approval as a Companion
Diagnostic for Use with Patients with Thyroid Cancer
Tokyo, Japan – March 25th, 2024 - Medical and Biological Laboratories Co., Ltd. (CEO: Hiroki Ito, “MBL”),
a JSR Life Sciences Company, announced that the MEBGEN™ BRAF 2 Kit was approved by the Japanese
Ministry of Health, Labour and Welfare (MHLW) on February 21, 2024.
The MEBGEN™ BRAF 2 Kit is a companion diagnostic*1 for encorafenib and binimetinib, for which Ono
Pharmaceutical Co., Ltd. has submitted an application for partial change in manufacturing and marketing
approval, for an additional indication of “the treatment of radically unresectable BRAF-mutant*2 thyroidcancer”. By detecting BRAF gene mutations (V600E, V600K, V600D, V600R, and V600M) in DNA
extracted from thyroid cancer tissue, the MEBGEN™ BRAF 2 Kit will be used as an aid in identifying
thyroid cancer patients eligible for encolafenib and binimetinib combination therapy.

With this approval, the MEBGEN™ BRAF 2 Kit is expected to contribute to the timely personalized
treatment of patients with radically unresectable thyroid cancer based on the presence or absence of theBRAF gene mutations. MBL will continue to pursue national health insurance coverage for the MEBGEN™
BRAF 2 Kit.

Product Information:
Product Name: MEBGEN™ BRAF 2 Kit
A p p r o v a l N o .: 30600EZX00005000
Purpose of use: Detection of BRAF gene mutations (V600E, V600K, V600D, V600R and V600M) in
DNA extracted from cancer tissue
Used as an aid in identifying thyroid cancer patients eligible for encolafenib andbinimetinib combination therapy
Testing method: PCR-rSSO
Package Size: 48 tests/ kit
Shelf life

: 12 months*1…What is a companion diagnostic?
Companion diagnostics refers to testing a particular drug in advance of treatment to determine whether itwill be effective for the patient and whether there is a significant risk of side effects.
MBL offers services for the development of companion diagnostics. For more information, please visit
https://www.mblbio.com/cdx/*2…What is BRAF gene mutation?
BRAF protein is a serine/threonine kinase that is a component of the Ras/Raf/MEK/ERK signaling pathway.

[PRESS RELEASE]
When the BRAF gene mutation results in the production of abnormal BRAF protein, unregulated cellproliferation leads to cancer.
Combination therapy with encorafenib and binimetinib is expected to be a promising therapeutic option forradically unresectable BRAF-mutant thyroid cancer, as BRAF V600 mutations are widely observed inthyroid cancer.

Contact:
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: https://www.mblbio.com/e/contact/

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 thefield of oncology, MBL is contributing to personalized medicine by developing companion diagnostics. For
more information, please visit https://www.mblbio.com/cdx/