BPM’s DNlite-IVD103 Secures Regulatory Approval in Singapore
Bio Preventive Medicine Corp. ("BPM", Stock Code: 6810) announced today that its proprietary innovative diagnostic test, DNlite-IVD103, has officially received marketing authorization from the Health Sciences Authority (HSA) of Singapore. The approved indication is for the risk assessment and prediction of Diabetic Kidney Disease (DKD) in Type 2 diabetes patients.
A Strategic Gateway to the ASEAN Market
Dr. Karen Tseng, Chairman and CEO of BPM, stated that Singapore currently faces the world's highest rate of chronic renal failure induced by diabetes. As a pioneer in the adoption of innovative healthcare solutions within the ASEAN region, Singapore’s approval is a landmark milestone. Following successful entries into Malaysia, Thailand, Vietnam, and Indonesia, this HSA certification serves as a powerful catalyst for BPM’s expansion across Southeast Asia.
Addressing the World's Highest DKD-to-ESRD Ratio
A study by the Saw Swee Hock School of Public Health at the National University of Singapore predicts that the number of diabetic adults in the city-state will reach 1 million by 2050 (a 40% increase from 2021), with annual economic costs projected at $1.867 billion USD. In response, the Singaporean government has been exceptionally proactive. Since declaring a "War on Diabetes" in 2016, authorities have launched aggressive health initiatives, including the world’s first ban on advertisements for high-sugar beverages and the mandatory "Nutri-Grade" labeling system.
Riding the "CKD Tsunami" with Precision Medicine
Dr. Tseng further noted that the local medical community has described the escalating crisis as a "CKD Tsunami." This heightened focus on DKD prevention and co-management creates a definitive market opportunity for DNlite-IVD103. "Our next step is to aggressively establish local marketing channels and work with distributors to integrate DNlite-IVD103 into the government's health insurance and reimbursement systems," said Dr. Tseng. "Our goal is to see DNlite-IVD103 adopted into national clinical guidelines and eventually established as a routine diagnostic standard." BPM remains committed to pursuing further regulatory certifications in other ASEAN countries to deepen its regional footprint and provide life-saving early detection to patients worldwide.
Related Links:
東協市場再下一城 新穎生醫DNlite-IVD103獲星上市許可 時報
新穎生醫東協邁步 DNlite-IVD103獲星國上市許可 MoneyDJ
新穎檢測試劑 獲新加坡上市許可 工商時報
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