[PRESS RELEASE]

MBL received MHLW approval for its MEBGEN™ mycobacterial nucleic
acid identification kit
Tokyo, Japan - August 26, 2024 - Medical ＆ Biological Laboratories Co., Ltd. (CEO: Hiroki Ito), a JSR
Life Sciences Company, announces that they received the Japanese Ministry of Health, Labour, andWelfare (MHLW) approval on June 27, 2024 for the MEBGEN™ mycobacterial nucleic acid identification
kit.
MEBGEN™ mycobacterial nucleic acid identification kit is a reagent for the detection of Mycobacterial DNA
in sputum or cultured mycobacteria. It can identify a total of 28 species of Mycobacterium tuberculosis (TB)
and non-tuberculosis mycobacteria (NTM), such as Mycobacterium avium complex (MAC), Mycobacterium
kansasii, Mycobacterium abscessus species, etc., in a single test.
In the past, it took four to eight weeks to determine test results due to the need for culture for identification
testing, but MEBGEN™ mycobacterial nucleic acid identification kit allows easier and earlier detection andidentification of bacterial species directly from sputum. It is expected to lead to early diagnosis and early
treatment of TB and NTM diseases.
MBL will begin procedures to secure insurance coverage for the rapid clinical implementation of thereagent.
About pulmonary TB and NTM diseases
Pulmonary TB (pTB) and NTM diseases (pNTM) are respiratory tract infections caused by Mycobacterium
tuberculosis or non-tuberculosis mycobacteria. In recent years, while the incidence rate and the numberof new cases of pTB have been decreasing in Japan, the number of patients with pNTM have been
increasing rapidly. In a national survey of 2014, the incidence of pNTM were reported to be 14.7/100,000
persons, higher than that of pTB and approximately 2.6 times higher than in the survey of 20171).
MAC is known as the most frequently isolated NTM in clinical practice. However, there are many otherspecies such as Mycobacterium kansasii and Mycobacterium abscessus species, and the clinical course
and treatment differ in each species, so it is very important to identify the species 2.
However, it is difficult and time-consuming to identify mycobacterial species due to the difficulty of isolating
and culturing some species and the presence of mixed infection with Mycobacterium tuberculosis ormultiple NTMs. Therefore, accurate and rapid identification is required in better clinical practice.

Product information;[In vitro Diagnostics]
Product name:

MEBGEN™ mycobacterial nucleic acid identification kit

Approval No.:

30600EZX00020000

Intended use:

Detection of Genus Mycobacterium（M. tuberculosis, M. tuberculosis var. BCG, M.
avium, M. intracellulare, M. chimaera, M. kansasii, M. abscessus subsp. abscessus,M. abscessus subsp. bolletii, M. abscessus subsp. massiliense, M. chelonae, M.
gordonae, M. xenopi, M. fortuitum, M. szulgai, M. marinum/ulcerans, M.
scrofulaceum, M. simiae, M. asiaticum, M. lentiflavum, M. nonchromogenicus, M.
shimoidei, M. terrae, M. shinjukuense, M. mucogenicum, M. peregrinum, M. trivialis,M. malmoense, M. heckeshornense）DNA in sputum or culture medium (to aid inthe diagnosis of tuberculosis or non-tuberculosis mycobacterium tuberculosis)

Testing method:

PCR-rSSO

Package:

96 wells

Shelf life:

12 months

Reference:1）Namkoong H, et al Emerg Infect Dis. 20162）National Institute of Infectious Diseases, Infectious Diseases Weekly Report, 2003, 7Contact:
Medical & Biological Laboratories Co., Ltd.
Head Quarter: SUMITOMO FUDOSAN SHIBADAIMON NICHOME BLDG. 2-11-8 Shibadaimon, Minatoku, Tokyo 105-0012 Japan
TEL: +81-3-6684-6860
Contact us: https://www.mblbio.com/e/contact/
About Medical & Biological Laboratories Co., Ltd.:
Medical & Biological Laboratories (MBL) was established in 1969 as the first antibody manufacturer inJapan, and researches, develops, manufactures, and sells reagents of in vitro diagnostics (IVD) andreagents 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 intractablediseases. In the field of oncology, we are contributing to personalized medicine by developing companion
diagnostics that predict the effects of drugs.