DNlite-IVD103 Achieves Another Milestone, Securing Endorsement from Global Medical Authorities

 As the global diabetes clock continues to tick faster, the worsening of related complications and comorbidities has become a critical health issue worldwide, prompting calls for proactive preventive actions. Among these, the use of innovative biomarkers as preventive guidelines for assessing Diabetic Kidney Disease (DKD) risk has garnered widespread attention and discussion. Bio Preventive Medicine Corp. ("BPM", Stock Code: 6810) announced today that an independent study utilizing BPM's innovative kidney disease biomarker, DNlite-IVD103, presented at the recent American Diabetes Association Annual Scientific Sessions (ADA 2024) in Orlando, concluded that DNlite serves as an effective tool for distinguishing different DKD phenotypes in patients with Type 2 diabetes.     

Validated by Top European Experts at ADA 2024

This study once again validates DNlite's powerful diagnostic capabilities in the field of precision diabetes medicine, effectively compensating for the clinical shortcomings of current Urinary Albumin-to-Creatinine Ratio (UACR) and estimated Glomerular Filtration Rate (eGFR) tests, and drawing significant attention and positive feedback from attendees. The research findings presented at this year's ADA annual meeting were co-authored by eight researchers, led by Professor Monia Garofolo from the University of Pisa, Italy. All authors are leading experts in the fields of diabetes and metabolism. Professor Garofolo also serves as a medical consultant for Novo Nordisk and Eli Lilly. Furthermore, co-author Professor Stefano Del Prato is not only a Professor of Endocrinology and Metabolism at the University of Pisa School of Medicine but also a prominent member of both the ADA and the European Association for the Study of Diabetes (EASD). Last year, Professor Del Prato co-authored an independent study titled "Clinical Outcomes and Biomarkers in Diabetic Kidney Disease" at EASD, yielding the same validating results.

Dr. Karen Tseng, Chairman and CEO of BPM, stated: "Although our company did not attend ADA this year, we are deeply gratified to once again receive recognition and endorsement from global authorities in the diabetes medical community." This validation perfectly aligns with the findings of the world's first multinational, cross-ethnic, long-term clinical study integrating data from Taiwan and Europe, which BPM published last year in the American Journal of Nephrology (AJN).

Expanding Global Reach and POCT Commercialization 

Currently, DNlite-IVD103 has obtained market authorizations in multiple countries globally, including the EU, Taiwan, Malaysia, Thailand, Vietnam, Indonesia, Saudi Arabia, and the United Arab Emirates. In addition to continuing to perfect its regulatory layout and secure approvals, BPM is actively expanding commercial partnerships and initiating a technology-licensing business model. 

Recently, BPM signed a Memorandum of Understanding (MOU) with South Korean listed company Boditech Med. This agreement licenses DNlite-IVD103 to the Korean partner for integration into Point-of-Care Testing (POCT) products. Together, the two parties aim to capture the massive disease management and remote care opportunities presented by the global population of over 500 million diabetic patients.

Addressing the Global "Diabetes Clock" and the Diagnostic Blind Spot 

According to United Nations statistics, the global diabetic population has reached a staggering 537 million, with one person developing diabetes every 5 seconds on average. The "diabetes clock" is accelerating, and diabetes imposes a massive financial burden on healthcare expenditures worldwide. Given the current diagnostic window (blind spot) in gold-standard DKD testing, the international medical community has begun advocating for the use of biomarker testing to improve existing care models.

Aligned with the Latest KDIGO 2024 Guidelines

BPM pointed out that KDIGO, an international organization comprised of global nephrology experts, had not updated its clinical practice guidelines for Chronic Kidney Disease (CKD) for 12 years. During this period, medical advancements have progressed rapidly—not only have there been significant leaps in pharmacological treatments, but products utilizing kidney disease biomarkers for risk assessment have also successively emerged.

In the latest 2024 KDIGO Clinical Practice Guideline, diagnostic tools developed using innovative biomarkers as parameters are now recommended. These tools are applicable to kidney patients across all CKD stages, including early stages (where kidney function and albumin levels still appear normal), serving as predictive risk assessment tools. This compensates for the inadequacies of current methods, assists in the early detection of high-risk patients, enables earlier pharmacological interventions, and ultimately delays CKD progression.     

The newly formulated global clinical care and treatment guidelines explicitly state that using kidney disease biomarkers for risk assessment has become a prevailing trend. BPM is actively participating in national-level programs both domestically and internationally, assisting in the promotion and establishment of a comorbidity care ecosystem for diabetes and CKD. The company anticipates that DNlite will become a guideline-recommended indicator for prognostic risk assessment of related kidney diseases. This will not only benefit a vast number of kidney patients but also generate stable profitability and sustainable growth for the company.

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