[Edaily Reporter NA EUN-KYUNG ] In vitro diagnostics company Precision Biosensor Inc.(335810)announced on the 4th that it has obtained domestic manufacturing certification for its glycated hemoglobin (HbA1c) immunoassay product, “Exdia HbA1c.” With this certification, the company has expanded its domestic immunoassay portfolio to include blood glucose management, following its existing offerings in cardiovascular disease, infectious diseases, and hormone testing.

Glycated hemoglobin (HbA1c) is a marker that reflects the average blood glucose level over the past 2–3 months. Since it is relatively less affected by meals or exercise on the day of testing, it is used for diagnosing diabetes and long-term blood glucose management. The American Diabetes Association (ADA) classifies HbA1c levels of 6.5% or higher as diabetes and levels between 5.7% and 6.4% as prediabetes. According to the Korean Diabetes Association, approximately 6 million adults aged 30 and older in South Korea have diabetes, and the population in the prediabetes stage is estimated at about 16 million, leading to projections that demand for related tests will continue to rise.

Industry observers note that since the change in the largest shareholder from #i-SENS, Inc. to #KwangdongPharmaceutical, an environment has been established that allows Precision Biosensor Inc. to more actively expand its business in the blood glucose management sector. While there was some overlap in business areas—as the previous largest shareholder, i-SENS, Inc., primarily focused on continuous glucose monitoring (CGM) and blood glucose monitoring (BGM) devices—analysts note that there is now greater scope to expand a unique product portfolio in the chronic disease diagnostics sector.

“Xdia HbA1c” is a point-of-care testing (POCT) product that uses capillary blood as a sample and provides test results within approximately 7 minutes. Following the glycated hemoglobin test previously offered on its existing clinical chemistry platform, “Xdia PT10,” the company now supports the same test on its immunodiagnostic platform, “Xdia TRF Plus.” Medical institutions already using Xdia TRF Plus can expand their test menu without having to purchase additional equipment.

Furthermore, the company expects that using this test in conjunction with the Xdia PT10’s renal function, liver function, lipid, and inflammation tests—which allow for the simultaneous assessment of blood glucose levels and major organ function—will enhance the efficiency of chronic disease management at primary care facilities.

Precision Biosensor Inc. supplies its point-of-care immunoassay platform, Xdia TRF Plus, and its clinical chemistry platform, Xdia PT10, to global markets including Europe and Japan. Building on this certification, the company plans to strengthen its penetration of the domestic blood glucose management market, apply for approval from a European Institutional Review Board (IRB) in the second half of this year, and pursue clinical trials and In Vitro Diagnostic Medical Devices Regulation (IVDR) certification by 2027.

Precision Biosensor Inc. official stated, “This certification has laid the groundwork for us to supply HbA1c immunoassay products in the domestic market as well,” adding, “We will continue to expand our lineup of tests that are in high demand in clinical settings and pursue entry into global markets alongside the domestic market.”