BPM into the Latin American Market, DNlite-IVD103 Receives Market Approval in Guatemala
Bio Preventive Medicine, BPM Announces DNlite-IVD103 Receives Market Approval in Guatemala.
On the 19th, BPM announced that its self-developed innovative IVD reagent, DNlite-IVD103, has received market approval from the Guatemalan Ministry of Health. This reagent is designed for assessing the risk of diabetic kidney disease (DKD) in type 2 diabetes patients and for monitoring the prognosis of kidney transplant (KT) patients. It is the first innovative biomarker IVD product from Taiwan to successfully enter the Latin American market.
BPM has also submitted market approval applications in Mexico and Brazil, aiming to progressively establish its presence in the Latin American market and capitalize on the significant opportunities in disease management.
According to the International Diabetes Federation (IDF), the diabetes prevalence rate among the 20 to 79 age group in Guatemala was 13.1% in 2021, with an estimated 1.15 million people affected. Government spending on diabetes-related medical costs reached $1.02 billion. The data also indicates that there are an estimated 560,000 undiagnosed diabetes cases, suggesting that the actual number of diabetes patients may be underestimated.
Looking at the entire Latin American region, there were 32.5 million diabetes patients in 2021, with over 10.67 million estimated undiagnosed cases. The region's government expenditure on diabetes-related medical care reached $65.28 billion in 2021, highlighting the urgent need for new preventive diagnostic tools.
BPM's Chairman, Tzu-Ling (Karen) Tseng, stated that diabetes can lead to life-threatening complications and impose a significant medical burden. Governments worldwide must address the public health crisis caused by uncontrolled diabetes, and the international medical community is calling for the use of biomarker testing to improve existing disease management guidelines and comorbidity care systems. Following the approval of DNlite-IVD103 in Guatemala, the current president of the Latin American Society of Nephrology (Dr. Vicente Sánchez Polo) will lead the promotion and sales efforts with the full support of local distributors.
BPM highlighted that DNlite-IVD103 is the world's first ELISA IVD reagent used for the rapid deterioration prevention of diabetic kidney disease. It has received market approval in multiple countries and continues to undergo clinical validation to accelerate market expansion. Research has confirmed that DNlite-IVD103 provides robust testing capabilities for early prevention and monitoring of kidney function, effectively complementing existing urine albumin (UACR) and estimated glomerular filtration rate (eGFR) tests. It offers comprehensive monitoring for diabetes patients' kidney management, preventing rapid deterioration of kidney disease, and can be used for monitoring kidney function prognosis in transplant cases.
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