BPM’s DNlite-IVD103 Secures Regulatory Approval in Vietnam, Expanding Southeast Asian Footprint Following MENA Export Success

Following the successful execution of an exclusive distribution agreement with a Kuwaiti partner for select countries in the Middle East and North Africa (MENA) region and the commencement of official shipments, Bio Preventive Medicine Corp. ("BPM") announces another major triumph in its Southeast Asian expansion. Its proprietary innovative in vitro diagnostic (IVD) test, DNlite-IVD103, has been granted marketing authorization by the Ministry of Health (MOH) of Vietnam. The approved indication is for the risk assessment and prediction of Diabetic Kidney Disease (DKD) in patients with Type 2 diabetes.

Addressing the Diagnostic Blind Spot in Traditional Testing

BPM noted that the current method for routine monitoring of DKD involves measuring urinary albumin (UACR: Urine Albumin-to-Creatinine Ratio) to evaluate the diagnosis through a staged progression: "Normal → Microalbuminuria → Nephropathy." However, recent domestic and international clinical studies have revealed that approximately half of patients do not follow this traditional pattern of continuously elevating albumin levels. Consequently, they often miss the critical window for treatment, leading to irreversible kidney damage.

A Massive Unmet Need and Changing Global Guidelines

Statistics indicate that about 50% of dialysis patients reach end-stage renal disease due to DKD. Recognizing the massive unmet medical need in current diagnostic practices, the international medical community continues to strongly advocate for the use of biomarker testing to improve existing care models and has begun focusing on the necessity of revising global clinical care and treatment guidelines.

Accelerating Global Adoption

DNlite-IVD103 is the world's first ELISA-based diagnostic test designed to prevent the rapid progression of DKD. Prior to this, the test had already obtained market authorizations in multiple EU countries, Taiwan, Malaysia, Thailand, Saudi Arabia, and the United Arab Emirates. The recent approval in Vietnam further demonstrates that DNlite-IVD103 has been widely recognized by the international medical community and is being progressively adopted into standard clinical practice.

Capitalizing on Vietnam's Surging Healthcare Demand 

According to data from the International Diabetes Federation (IDF), the diabetic population in Vietnam exceeded 3.99 million in 2021, with a prevalence rate of 6.1%—a figure that has doubled over the past decade. The Vietnamese government's diabetes-related healthcare expenditures reached a staggering $1.67 billion USD, highlighting a massive underlying demand for precision medical services and diagnostics. Following the successful market authorization of DNlite-IVD103, BPM will actively formulate subsequent market strategies to drive robust revenue growth and commercial momentum in the region.