■　Latest genotype analysis system provided to Thailand Clinical research begins to verify the method to guide appropriate use of AIDS drugs based on genetic information

Towards the realization of personalized medicine with an international project using a small genotype analysis system

June 22, 2009
Toppan Printing

RIKEN GENESIS
RIKEN

By applying this system in medical practice, it will be possible to improve the quality of medical treatment for AIDS patients in Thailand and reduce unnecessary medical costs. It is therefore considered that it could be an important international contribution by Japan.

This clinical research will also be a major step forward in the realization of personalized medicine in which appropriate treatment is given to each individual patient according to genetic information.

 

Background

Personalized medicine provides effective treatment and administration of drugs to each individual on a scientific basis with consideration for the genetic background of the patient. With this type of medicine, the quality of life of each patient is improved and it will lead to the reduction of medical costs that grow every year in Japan, with an anticipated 4 to 5 trillion yen reduction in costs arising from the side-effects of drugs.
In aiming to realize personalized medicine, one type of DNA polymorphism (※2), namely SNP (Single Nucleotide Polymorphism:※3), is receiving attention as a means to predict individual genetic differences, the effectiveness of medicines, and whether someone is susceptible to particular illnesses. Currently, research is underway to ascertain the relationships between SNP and various diseases and medicines. If small analysis systems that enable prompt and easy determination of the combination (haplotype) of SNP genotypes in actual medical practice become widely used, it will be possible to give effective treatment that is matched to the characteristics of the individual and it will no longer be necessary to make patients wait a long time for the results of tests.

For these reasons, currently research and development is ongoing for genotype analysis systems that will enable personalized medicine even without a high level of training or knowledge regarding the test; and with clinical research underway in actual medical practice, the realization of personalized medicine is just a step away.

 

Toppan Printing, RIKEN GENESIS (※4) and RIKEN are jointly conducting this research and development of genotype analysis systems and in 2008 completed the small "TPSA-003" prototype which can carry out the test within 1 hour.

 

Overview of the clinical research

In the Asian region, the spread of AIDS occurred relatively early in Thailand, with the situation becoming serious around 1990, and it continues to be a social problem of significant concern.

AIDS drugs and drugs that prevent the onset of disease and mother to infant transmission in AIDS sufferers have to be taken every day. However, because the price of AIDS drugs is high, there is a significant financial burden.　As a relatively cheap AIDS drug, Thailand has made Nevirapine its first choice for treatment but at 21% the extremely high frequency of the side effects, which are serious inflammation (drug rashes) in areas such as the skin, mucous membranes and eyes, has become a problem.

 

The RIKEN Center for Genomic Medicine has discovered a DNA polymorphism marker that shows a strong link with the occurrence of drug rashes caused by Nevirapine. In order to make use of this discovery in clinical practice, RIKEN, Toppan Printing and RIKEN GENESIS have jointly developed a genotype analysis system that predicts the risk of side-effects developing.

　

Using this genotype analysis system, clinical research will be commenced targeting the reduction of the strain on the patient's health and also the reduction of medical costs.

・　Schedule for clinical research: 18 months from April 2009 to September 2010

・　Number of subjects: 2200 patients suffering from AIDS (gathered from a total of 10 hospitals including the one attached to Mahidol University)

・　Testing method: Nevirapine will be administered to half of the patients (1100). From the remaining 1100 patients, treatments that do not involve the administration of Nevirapine will be provided for patients determined by the genotype analysis system to be at risk from drug rashes.

The results from the 2 groups will be analyzed and the effectiveness of the risk prediction will be verified.

 

Overview of the genotype analysis system

This genotype analysis system predicts the risk of rashes occurring by identifying DNA polymorphism markers that indicate a high correlation with the risk of the occurrence of drug rashes that are a side effect of the AIDS drug Nevirapine.

・　Number of systems provided: 2

・　External dimensions: 400(W)×730(D)×630(H) mm

・　Weight: approximately 50kg

・　Sample: Genome DNA

・　Analysis time: 60 mins / 2 samples

・　Chip: Disposable type (2 samples / chip)

 

Further developments

Toppan Printing, RIKEN GENESIS and RIKEN will conduct research and development of genotype analysis systems that can be used for various applications including genetic testing prior to drug administration. In the future, this research and development will be made use of in a wide range of medical practice and the realization of personalized medicine will be pursued.

 

―　Supplementary explanation　―

（※1） Genotype analysis system: It has been discovered that due to differences in specific parts of DNA, there are differences between individuals in terms of susceptibility to side-effects of medication and to certain diseases. Systems that analyze and identify these differences in specific parts of DNA are called genotype analysis systems and are receiving attention as they are able to predict the occurrence of side-effects or disease through prior testing.

 

（※2） DNA polymorphism: This refers to the individual differences in the genome sequence, which is said to have approximately 3 billion base pairs, caused by the occurrence of differences in the base sequence due to factors such as mutations and genetic recombination of homologous chromosomes. The positions of genes give rise to significant differences such as in skin or eye color, or resistance to medicines, and these characteristics are inherited.

 

（※3） SNP (Single Nucleotide Polymorphism）: Within DNA polymorphism there are places where single nucleotides from the genome sequence differ between individuals. This is called single nucleotide polymorphism. Since these differences give rise to differences between individuals such as in terms of responsiveness to medications and susceptibility to disease, through testing it is possible to administer medicine and give treatment that is matched to the individual patient.

 

（※4） RIKEN GENESIS CO.,LTD. (http://www.rikengenesis.jp/en/）:　With a foundation of the SNP typing technology developed by the RIKEN Center for Genomic Medicine, RIKEN GENESIS was established on October 15, 2007 through joint investment by RIKEN Venture Capital Co. Ltd. (President: Akito Arima) and Toppan Printing. In technical collaboration with RIKEN, the company provides SNP typing analysis services, engages in business for analysis systems and related services, and targets the improvement of each individual's quality of life through the realization of personalized medicine.

 

【Inquiries about this press release】
RIKEN GENESIS CO., LTD.
Sales & Marketing Development Department
TEL: 045-521-8781 / FAX: 045-521-8786 / e-mail: info2@rikengenesis.jp