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NGeneBio Gets CE-IVD Mark for HLA Typing Assay

NEW YORK — South Korean diagnostics firm NGeneBio said on Tuesday that it has received CE-IVD marking for its next-generation sequencing-based human leukocyte antigen (HLA) typing assay.

According to NGeneBio, the HLAaccuTest detects 11 HLA gene loci in order to verify the histocompatibility between bone marrow or organ donors and recipients prior to transplantation. A version of the test covering five loci was previously launched in South Korea.

NGeneBio CEO DaeChul Choi said in a statement that with the CE-IVD marking, the company is setting its sights on international markets for HLA testing, beginning with Europe.

Following a $32 million initial public offering in South Korea earlier this year, NGeneBio began increasing its headcount in R&D, sales and marketing, and business development as part of its global expansion plans. It is also aiming to partner with a CLIA lab in the US next year to facilitate test submissions to the US Food and Drug Administration.

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