Geninus Japan Subsidiary GxD Signs Contract with Japanese CLIA Certification Agency CGI K.K.

Geninus, a genome analysis specialist company (CEO Park Woong-yang), announced on the 25th that its Japanese subsidiary GxD has signed a contract with Japan's CGI K.K. (hereinafter CGI) to obtain CLIA (Clinical Laboratory Improvement Amendments) certification.

CLIA certification is a standard certification for clinical laboratories overseen by the CDC (Centers for Disease Control and Prevention, USA). This certification is mandatory for laboratories testing human-derived specimens for the diagnosis, prevention, or treatment of diseases. It is also a required standard certification for operating LDT (Laboratory Developed Test) services and analyzing specimens for FDA (U.S. Food and Drug Administration) clinical trials.

Japan's CGI, established in 1990, is a laboratory quality management consulting company that was the first in Japan to introduce laboratory quality and related certification systems such as CAP (College of American Pathologists) and ISO 15189. In addition to CAP, CGI holds a unique influence in obtaining CLIA certification in Japan and has supported the certification of all four CLIA labs existing in Japan as of the first half of this year.

Through this contract, Geninus's subsidiary GxD and CGI plan to complete GxD's CAP certification within 2024 and proceed with the CLIA certification acquisition process. Japan is a country where clinical trials for new drugs targeting Asians by global pharmaceutical companies are mainly conducted, and it is expected to become the largest potential market in Asia for single-cell CRO services in the future.

Geninus CEO Park Woong-yang stated, “Through GxD's acquisition of CLIA certification, it will be possible to provide single-cell analysis services for clinical trials of global pharmaceutical companies in Japan.” He added, “Earlier this year, Geninus introduced the concept of ‘single-cell CRO’ for the first time in Korea and has been leading the market. The year 2024 will be the inaugural year for entering the global single-cell CRO market beyond Korea through GxD.”

Meanwhile, Geninus launched ‘DrugGPS,’ a single-cell CRO service for clinical sample analysis targeting pharmaceutical companies, in March, and established and operates its Japanese subsidiary GxD in July.