Takara Advanced Biomedical Center, one of Takara Shuzo Biomedical Groups, is registered as an examination laboratory for public health. This laboratory plans to start services for gene analysis in this year that will be employed to predict the effectiveness of anti-cancer and anti-microorganism drugs to be used in therapeutic treatments. In this analysis, cancer cells or infected microorganisms isolated from patients are tested whether they have a genetic background responsible to resistance to anti-cancer or anti-microorganism drugs.

In the gene analysis concerning to antibiotics, the presence of mutations in genes for resistance to fluoroquinolones, rifampin or macrolide antibiotics is examined by using cells from patients. Infectious bacteria of concern are Neisseria gonorrhoeae, Mycobacterium tuberculosis, and Helicobacter pyroli. For cancer cells, mutational analysis and gene expression analysis are performed in genes responsible to resistance to anti-cancer drugs such as 5-fluorouracil, cisplatin, and Pacitaxel (Taxol^®) to predict their effectiveness for each patients. The subjects of the analysis are stomach, colon, lung, breast cancers, etc.

Examination of the resistance has usually been performed by using a phenotype method, in which the microorganisms or tumor cells are cultured in vitro with the drugs to determine sensitivity. This method takes a week to a month to complete the medical diagnosis. On the other hand, the Biomedical Group has developed a rapid method to detect mutations and to analyze expression of the genes using specific probes for amplified genes in a day. This method can serve as a virtual phenotype examination to predict rapidly the phenotypes in advance, and can probably facilitate drug discovery and clinical trials.

A part of the services has already been performed for research purpose by commission from pharmaceutical industries and universities. The Group will expand the services by increasing examination items and cooperating with sixteen laboratories for public health. The services will be done under regulation of the Group's committee of ethical operation in compliance with both "the guideline for ethical analysis of human genes on commission" issued by the Association of Examination Laboratories for Public Health and "the guideline for ethical researches on analysis of human genome and genes" issued by the Ministry of Health, Labour and Welfare and two other ministries.

This article is translated from the press release in Japanese for your convenience.