NGeneBio Receives CE-IVD Mark for Organ Donation Typing Assay

South Korea-based NGeneBio has earned a CE-IVD mark for its HLAaccuTest, a next-generation human leukocyte antigen (HLA) typing assay.

The test, which looks for 11 HLA gene segments, is used to confirm compatibility between bone marrow or organ donors and recipients prior to transplantation procedures.

A previous version of the test that identified just five HLA gene segments is already marketed in South Korea. The company said it now plans to launch the new test in markets that accept the CE-IVD mark.