NGeneBio, a precision diagnostics platform company, has received approval from the Thai Food and Drug Administration (TFDA) to market HLAaccuTest™ All, an in vitro diagnostic medical device based on next-generation sequencing (NGS) technology.

It is the fourth NGS-based product approved for registration in Thailand, the company said on Thursday.

HLA (Human Leukocyte Antigen) is a protein on the surface of human tissue cells or blood cells and plays an important role in the body's immune response. In organ or bone marrow transplantation, HLA matching between donor and recipient is essential to predict rejection, according to NGeneBio.

The newly licensed HLAaccuTest™ All identifies 11 genes in high resolution, overcoming the ambiguity that makes existing tests difficult to read and improving the accuracy of the analysis. That allows for faster identification of suitable recipients, increasing the success rate of organ and bone marrow transplants and minimizing side effects.

EasyHLAanalyzer™, the analysis software that comes with all HLAaccuTest™ products, is designed to automatically analyze HLA data quickly and accurately, enabling a one-stop solution from HLA genotype reading to clinical report generation, which will greatly improve work efficiency in the clinical field.

"The approval by the Thai Food and Drug Administration has once again proven the superior quality and clinical efficacy of our products in the Southeast Asian market," CEO Choi Dae-chul said. "We will build on this achievement to achieve meaningful results through more active global activities and cooperation with diagnostic companies."

According to a report by global research firm Business Market Insights, the HLA testing market in the Asia Pacific region is expected to reach $243.18 million (324.7 billion won) by 2028, growing at an annual average rate of about 8 percent from $154.35 million in 2022.