5 February 2018
Dow Biomedica, partner of GenDx in South Korea, has completed the IVD registration of the NGSgo® Workflow for typing of HLA-A, B, C, DRB1, and DQB1 on Illumina Miseq platforms and analysis with NGSengine®. The Korean Ministry of Food and Drug Safety (MFDS) has released the official IVD certificate this week. This makes NGSgo® the first NGS workflow that is registered as IVD for HLA typing in South Korea. NGSgo reagents and software will be distributed as diagnostic products for HLA typing by GenDx’s local distributor Dow Biomedica.
Dr. Wietse Mulder, CEO of GenDx, commented: “With our local partner Dow Biomedica, headed by Mr. Y.G. Shin, CEO, we have worked intensely together to validate and document the NGSgo workflow according to the South Korean IVD regulations. It took a great deal of work to complete the registration, and we are proud to be the first supplier that can offer IVD NGS products for HLA typing in South Korea.”
Readers of this message, who are interested in NGSgo® product line and wonder whether they could benefit from this registration, can receive more information by contacting Dow Biomedica at firstname.lastname@example.org or contacting GenDx directly.
Complete press release