On the 19th, Bio Preventive Medicine announced that its innovative diagnostic reagent, DNlite-IVD103, has received market authorization from the Ministry of Health of Guatemala. The approved indications include risk assessment for diabetic kidney disease (DKD) in patients with type 2 diabetes and prognostic monitoring for kidney transplant (KT) patients. This makes it the first innovative biomarker IVD product from Taiwan to successfully enter the Latin American market.
The company has also submitted market authorization applications in Mexico and Brazil, aiming to further expand its presence in the Latin American market and tap into the substantial opportunities in disease care.
According to the International Diabetes Federation (IDF), in 2021, the prevalence of diabetes among Guatemalans aged 20 to 79 was 13.1%, with an estimated 1.15 million people affected. The government spent approximately $1.02 billion on diabetes-related healthcare costs. Additionally, it is estimated that over 560,000 people with diabetes remain undiagnosed, indicating a potential underestimation of the diabetes burden in the region.
In a broader context, Latin America had 32.5 million people with diabetes in 2021, with an estimated 10.67 million undiagnosed cases. The region's governments spent $65.28 billion on related healthcare, highlighting the urgent need for new preventive diagnostic tools.
Karen Tseng, Chairman of Bio Preventive Medicine, emphasized that diabetes often leads to life-threatening complications and places a significant burden on healthcare systems. Governments worldwide are increasingly recognizing the public health crisis posed by uncontrolled diabetes, and the global medical community is advocating for the use of biomarker testing to improve current treatment guidelines and comorbidity management systems. Following the approval of DNlite-IVD103 in Guatemala, the company will work closely with Dr. Vicente Sánchez Polo, the current president of the Latin American Society of Nephrology, along with local distributors, to accelerate the promotion and sales of DNlite-IVD103 in the region.
Bio Preventive Medicine stated that DNlite-IVD103 is the world's first ELISA diagnostic reagent designed for the early prevention of rapid deterioration in diabetic kidney disease. The product has already obtained market approval in multiple countries and continues to undergo clinical validation to expedite market adoption. Studies have consistently demonstrated that DNlite-IVD103 provides robust detection capabilities in the early prevention and monitoring of kidney function, effectively complementing and addressing the limitations of current urine albumin (UACR) and estimated glomerular filtration rate (eGFR) tests. The reagent enables comprehensive management of kidney disease in diabetic patients, preventing rapid disease progression, and is also useful for monitoring kidney function prognosis in kidney transplant patients.
With the recent market authorization in Guatemala, Bio Preventive Medicine will collaborate closely with local distributors to develop subsequent marketing strategies and seek inclusion in disease treatment guidelines and insurance coverage to ensure stable revenue growth.
Resource (mandarin): 新穎生醫插旗拉美市場 DNlite-IVD103獲瓜國上市許可
