■　First-ever accreditation from the College of American Pathologists (CAP) in Japan for an independent facility carrying out contract genetic analysis:

Enabling the provision of world-class genetic analysis for pharmaceutical development

May 12, 2010

RIKEN GENESIS

RIKEN GENESIS CO., LTD., under the leadership of President Yusuke Tsukahara, received accreditation for its contract genetic analysis business from the College of American Pathologists (CAP) on May 11, 2010. This is the first time that an independent facility in Japan carrying out contract genetic analysis has received CAP accreditation.

 

CAP accreditation, which is granted through examination and inspection of clinical test laboratories, confers recognition of the technical standards of the systems. Over 7,000 medical testing facilities in over 40 countries have been accredited, mostly in the United States. CAP accreditation of RIKEN GENESIS is testament to the world-class quality assurance and reliability of technology employed in the company's genetic analysis. CAP accreditation means that results of genetic analysis carried out by RIKEN GENESIS will be accepted by the US Food and Drug Administration (FDA).

 

RIKEN GENESIS began offering cutting-edge, high-quality genetic analysis developed by the RIKEN Center for Genomic Medicine. In June 2009, RIKEN GENESIS introduced the RG-GLP （※1）, a quality assurance system for genetic analysis based on GLP ordinance for pharmaceuticals （※2）. The RG-GLP standards establish systems enabling RIKEN GENESIS to perform highly reliable drug trials and clinical studies for pharmaceutical companies and medical research institutions, and have produced concrete results.

 

Genetic background is likely to play a significant role in the appearance of drug side effects, and pharmacogenomics (see note) is being used to investigate the causes of side effects. Recently, it has become more common to collect and store genomic DNA of subjects who participate in clinical trials for new drugs, and pharmaceutical companies are actively beginning to analyze the genes of these subjects in order to develop drugs with even higher safety levels. RIKEN GENESIS is meeting the needs of domestic and foreign pharmaceutical companies and medical research institutions by providing cutting-edge genetic analysis with the highest levels of reliability.

 

RIKEN GENESIS will actively strive to make "Personalized Medicine" （※3） a reality, which is a fundamental mission of the company.

 

 

―　Supplementary explanation　―

■CAP
The College of American Pathologists (CAP), which is made up of pathologists and laboratory professionals, is the world's biggest academic society. The CAP implements programs such as the CAP Survey, an international clinical laboratory evaluation program covering over 23,000 clinical testing laboratories in 95 countries worldwide, and the Laboratory Accreditation Program (LAP), in which over 7,000 testing facilities worldwide take part. The CAP was founded in 1961 for the purpose of standardizing glucose tests, and provides surveys as programs for laboratory accreditation and laboratory comparison aimed at standardization. It is currently working for further global standardization by providing product management tools and educational programs.

 

（※1）RG-GLP (Riken Genesis - Good Laboratory Practice)

Since June 2009, genetic analysis and experiments have been carried out at RIKEN GENESIS in accordance with our RG-GLP, which is based on a Good Laboratory Practice (GLP) standard based on the Ministerial Ordinance of the Ministry of Health, Labor and Welfare for non-clinical studies in pharmaceutical safety based on regulations stipulated in the Pharmaceutical Affairs Law (partial revision of Ministry of Health, Labor and Welfare Ordinance No. 21; Ministry of Health, Labor and Welfare Ordinance No. 114 of June 13, 2008).

 

（※2）Pharmacogenomics (PGx)

Pharmacogenomics is the pharmacology of the genome. It is an approach that carries out research and development into drug discovery and administration on the basis of genomic information. It is defined in the Ministry of Health, Labour and Welfare's Glossary of Pharmacogenomics Terms as "research into variations in DNA or RNA characteristics that relate to drug responses".

（※3） Personalized Medicine

The provision of effective, scientifically based, individualized treatment and medication based on the genetic background of each patient. This treatment is expected not only to improve the quality of life (QOL) of each individual patient but also to reduce costs associated with adverse drug reactions and reduce the cost of healthcare in Japan, which is rising annually.

【Inquiries about this press release】
RIKEN GENESIS CO., LTD.
Corporate Management Department
TEL: +81-45-521-8781 / FAX: +81-45-521-8786 / e-mail: info2@rikengenesis.jp