Press Release:New in vitro diagnostic product which can simultaneously detect multiple RAS gene mutations in colorectal cancer

February 23, 2015
National Cancer Center
G&G Science Co., Ltd
in Japanese

National Cancer Center (President: Tomomitsu Hotta, Head Quarters: Chuo-ku, Tokyo, hereinafter referred to as NCC) and G&G Science Co., Ltd. (President: Yukiko Abe, Head Quarters: Fukushima City, hereinafter referred to as G&G Science) successfully created MEBGEN^TM RASKET KIT (RASKET KIT), a new IVD test kit to detect RAS gene mutations in unresectable advanced/ recurrent colorectal cancer, prior to administering anti-epidermal growth factor receptor (EGFR) antibodies. RASKET KIT was commercialized by Medical & Biological Laboratories Co., Ltd. (President: Jun Sasaki, Head Quarters: Nagoya City, hereinafter referred to as MBL).

RASKET KIT is the Japan’s first IVD test kit which can detect mutations in exon 2 (codon 12, 13), exon 3 (codon 59, 61), and exon 4 (codon 117,146) in both KRAS and NRAS genes in a single assay. MBL obtained CE mark approval in June, 2014 to market the product in Europe, and regulatory approval in Japan on January 27, 2015, as stated above.

The research group consisting of nine medical institutions in Japan carried out a comprehensive genetic analysis (BREAC trial) to identify potential new biomarkers of various mutations outside of KRAS exon 2 which correlate with poor therapeutic effects of anti-EGFR treatment on unresectable, advanced, recurrent colorectal cancer. Based on the results and findings from the BREAC trial and other studies, G&G Science and the multicenter study group led by Dr. Atsushi Ohtsu (Director of Exploratory Oncology Research & Clinical Trial Center), Dr. Katsuya Tsuchihara (Chief of Division of Translational Research, Exploratory Oncology Research & Clinical Trial Center), and Dr. Takayuki Yoshino (Chief of Department of Gastrointestinal Oncology, Hospital East) developed RASKET KIT which can simultaneously detect those newly found RAS mutations. The research and development was supported by strategic SME/venture development grant funding (2011) from the Japan Science and Technology Agency’s A-STEP program.

‘‘None of existing diagnostic kits could simultaneously detect multiple RAS gene mutations. RASKET KIT helps clinicians correctly select candidate patients for anti-EGFR antibody treatment and thus provide more appropriate and individualized treatments.’’ said Dr. Takayuki Yoshino, the principal investigator of the clinical evaluation trial for RASKET KIT.

For more details, please click on the links below.

• Press Release: New in vitro diagnostic product which can simultaneously detect multiple RAS gene mutations in colorectal cancer (PDF document) (PDF:76KB)
• RASKET study (the clinical evaluation trial for RASKET KIT) data will be published in EBioMedicine, an Elsevier journal published with editorial support from Cell Press and The Lancet.
• http://www.sciencedirect.com/science/article/pii/S2352396415000559