Takara Bio Inc. (president and CEO: Ikunoshin Kato, Ph.D.) will begin sales of a kit for detecting new-quinolone (fluoloquinolone) resistant gonococcus through its distributor Medca Japan Co., Ltd. (President: Yutaka Kannari) on December16. The kit amplifies certain genes of gonococcus using Takara Bio's original isothermal gene-amplification method (ICAN^TM), and then detects the point mutations, which confer new-quinolone resistance, using gold nanoparticles.

New-Quinolone, an antibiotic, shows a broad spectrum of anti-microbial activity. The use of new-quinolone has increased rapidly over the past few years as a specific medicine for infectious diseases. As the new-quinolone use increased, the spread of new-quinolone resistant bacteria has also become a serious problem. This resistance is caused by the mutations of gyrase A (GyrA) gene that relates bacterial growth. In particular, the number of gonorrheal patients is increasing over the past few years, because the spread of new-quinolone resistant gonococcus (and gonococcus infection spreads among younger generation).

Up to now, detections for new-quinolone resistant gonococcus have been done by a culture method known as the Disk Susceptibility method using a paper disk impregnated with the drug. However, this method requires three to five days to obtain the results and in some cases the results are ambiguous.

Takara Bio's detection kit uses Takara Bio's proprietary ICAN method to amplify the target Gyr A gene and then detect the point mutations, which cause new-quinolone resistance, using a hybridization chromatography method combined with gold nanoparticles. Test results are obtained in about 90 minutes as a red band that appears on the test strip. Thus, the kit enables fast, simple tests without any specialized equipment.

Collaborating with Medca Japan Co., we have already confirmed correlation between the conventional culture method (using nine types of new-quinolone) and Takara Bio's detection kit in detection of Neisseria gonorrhoeae strain separated from clinical human samples. Furthermore, Takara Bio's detection kit is able to clearly detect the point mutation of Gyr A gene in samples which show low level of new-quinolone resistance undetectable by the conventional culture method. Takara Bio's detection kit also can detect the point mutation in urine samples from gonorrheal patients.

This article is translated from news in Japanese for your convenience.