TBG Biotechnology Corp. have received the approval from the China Food and Drug Administration (CFDA) for a portfolio of high resolution Human Leukocyte Antigen (HLA) genotyping kits widely used in hematopoietic cell transplantation (HCT) in the treatment of leukemia, lymphoma, aplastic anemia and myelodysplastic syndromes. It is the first approval of its intended use in China and by law, once a CFDA approved product is available, all clinical laboratories should use CFDA approved products for clinical testing. Currently, TBG's HLAssure SE SBT Kits will be the only marketed products that can fulfill the requirement for high resolution HLA genotyping. The CFDA approved HLAssure SE SBT Kit portfolio covers HLA loci A, B, C, DRB1 and DQB1. These are the primary genetic targets currently used for assessing the compatibility between donors and the recipient. Other clinical applications for HLA high resolution typing include disease association with autoimmune diseases and prediction of susceptibility to drug hypersensitivity. The rapid growth in the number of HCT is partially due to the increasing availability of compatible donors. As all donors require HLA typing, it also makes up one of the larger segments of the HLA typing market. These donors can either be from related family members, China bone marrow registry, or the cord blood registries. Since 2003, the China bone marrow registry has accumulated 2,370,569 register donors and over 170,000 donor samples are HLA typed and added to the registry every year.