BPM Enters Latin America: DNlite-IVD103 Granted Market Authorization in Guatemala

Bio Preventive Medicine Corp. ("BPM", Stock Code: 6810) announced today (19th) that its proprietary innovative diagnostic test, DNlite-IVD103, has been granted market authorization by the Ministry of Public Health and Social Assistance of Guatemala. The approved indications include Diabetic Kidney Disease (DKD) risk assessment for patients with Type 2 diabetes, as well as prognostic monitoring for Kidney Transplant (KT) patients. This milestone makes DNlite-IVD103 the first innovative biomarker IVD product from Taiwan to successfully penetrate the Latin American (LATAM) market. BPM has also submitted regulatory applications for Mexico and Brazil, progressively completing its strategic layout in LATAM to capture massive healthcare market opportunities.     

According to data from the International Diabetes Federation (IDF), the diabetes prevalence rate among adults aged 20-79 in Guatemala reached 13.1% in 2021, translating to approximately 1.15 million people living with diabetes. The government's diabetes-related healthcare expenditures soared to $1.02 billion USD. The data also indicates that over 560,000 cases remain undiagnosed, suggesting the local diabetic population may be significantly underestimated. Zooming out to the broader Latin American region, the number of diabetic patients reached 32.5 million in 2021, with an estimated 10.67 million undiagnosed cases. Regional government healthcare expenditures for diabetes exceeded $65.28 billion USD in 2021, highlighting an urgent and unmet market need for novel preventive diagnostic tools.      

Dr. Karen Tseng, Chairman and CEO of BPM, stated that diabetes frequently leads to life-threatening complications and imposes a staggering medical burden. Governments worldwide are being compelled to address the public health crisis triggered by uncontrolled diabetes. The international medical community is increasingly advocating for the use of biomarker testing to improve current disease treatment guidelines and comorbidity care systems. Following the approval in Guatemala, the promotion and sales of DNlite-IVD103 in the local market will be accelerated under the leadership of Dr. Vicente Sánchez Polo, current President of the Latin American Society of Nephrology and Hypertension (SLANH), with the full support of local distributors.     

DNlite-IVD103 is the world's first ELISA-based diagnostic test designed to prevent the rapid progression of Diabetic Kidney Disease. It has already obtained market authorizations in multiple countries and continues to undergo clinical validation to accelerate market adoption. Extensive research has consistently proven that DNlite-IVD103 delivers powerful diagnostic capabilities in the early prevention and monitoring of kidney function. It not only effectively compensates for the clinical shortcomings of current Urinary Albumin-to-Creatinine Ratio (UACR) and estimated Glomerular Filtration Rate (eGFR) tests—comprehensively monitoring kidney disease management in diabetic patients and preventing rapid renal decline—but also serves to monitor renal prognosis following kidney transplantation.     

Following the receipt of the market authorization letter in Guatemala, the company will work closely with local distributors to formulate follow-up marketing strategies. BPM will aggressively strive for the inclusion of DNlite-IVD103 into disease treatment guidelines and health insurance reimbursement systems, aiming to generate a stable and consistent revenue stream. 

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