NEW YORK (GenomeWeb) – Australian molecular diagnostics firm TBG Biotechnology announced today that it has received approval from the China Food and Drug Administration for its HLAssure SE SBT portfolio of high-resolution human leukocyte antigen (HLA) genotyping kits for hematopoietic cell transplantation (HCT).
According to the company, the newly approved kits cover HLA loci A, B, C, DRB1, and DQB1 — the primary genetic targets currently used for assessing the compatibility between hematopoietic cell donors and recipients. HCT is commonly used in the treatment of leukemia, lymphoma, aplastic anemia, and myelodysplastic syndromes.
TBG said that its Xiamen, China-based subsidiary is currently in discussions with hematopoietic cell transplantation laboratory distributors and service providers about rolling out the kits in that nation.
“China has one of the fastest growing allogeneic HCT markets with a [compound annual growth rate] of over 18.9 percent,” Ifan Chiu, president of TBG’s Xiamen unit, said in a statement. “We were determined to be the first to provide a CFDA-approved, high-resolution typing solution for the HLA typing laboratories in China.”