BPM Secures CE IVD Mark for DNlite-IVD103

Bio Preventive Medicine Corp. ("BPM"), an innovative professional in vitro diagnostic (IVD) manufacturer, announced today the successful development of DNlite-IVD103, the world's first diagnostic kit designed to prevent the rapid deterioration of Diabetic Kidney Disease (DKD). The product has officially received the CE IVD mark for market authorization in the European Union.

With approximately 50% of global End-Stage Renal Disease (ESRD) cases originating from DKD, preventive testing for this condition has long been an unmet medical need. The European approval of DNlite-IVD103 marks the first time an innovative IVD from Taiwan targeting a chronic disease has successfully entered the international market. BPM is currently aggressively establishing its European sales channels, anticipating a "harvest period" starting in 2020 and propelling the company's operations into a new milestone.

Precision Management and Early Intervention

DNlite-IVD103 is the world's first innovative diagnostic reagent for the precision management of DKD. By detecting specific post-translational modifications (PTMs) of biomarkers in urine, the test can effectively predict the status of a diabetic patient's kidney function over the subsequent 1 to 2 years. If a risk of decline (i.e., a drop in the estimated Glomerular Filtration Rate, eGFR) is identified, physicians can recommend timely and appropriate treatments, allowing patients to capitalize on the golden window for therapy and potential recovery. Implementing the concept of early prevention and treatment is a tremendous boon for diabetic patients.

Overcoming the Limitations of Traditional Diagnostics

Dr. Karen Tseng, Founder and Chairman of BPM who has guided the company since its inception, stated that the current method for routine DKD monitoring is testing urinary albumin (UACR: Urine Albumin-to-Creatinine Ratio), assessing the disease through a staged progression from "Normal → Microalbuminuria → Nephropathy." However, in the early stages, simply observing microalbuminuria fails to achieve the sensitivity and specificity required for an accurate diagnosis, often causing patients to miss the opportunity for early treatment.

Robust Global Clinical Validation

Guided by the philosophy that "Prediction is better than detection," BPM has been dedicated to developing DKD diagnostic kits from the very beginning. To date, the development of DNlite-IVD103 has accumulated clinical data from over 3,000 patients globally. This robust foundation is supported by global clinical trials from European pharmaceutical giant Boehringer Ingelheim, the Taiwan Kidney Biomarker Consortium (comprising nephrology departments from Tri-Service General Hospital, Taichung Veterans General Hospital, Mackay Memorial Hospital, and Cathay General Hospital), Type 2 diabetes research led by Professor Lee-Ming Chuang of National Taiwan University Hospital, Type 1 diabetes research led by Professor Yen-Chin Lee of Mackay Memorial Hospital's Pediatrics Department, as well as multinational studies in the Netherlands and Japan.

Backed by this extensive clinical data, BPM's innovatively developed PTM detection technology effectively resolves the time-consuming and expensive bottlenecks of advanced biomarker testing, while simultaneously overcoming the insufficient sensitivity of traditional diagnostic methods.

Four Key Competitive Advantages of DNlite-IVD103

DNlite-IVD103 is performed using an ELISA (Enzyme-Linked Immunosorbent Assay) test, featuring streamlined operational steps and short analysis times for large sample sizes. It is widely applicable for on-site testing in general hospitals and diagnostic centers, effectively expanding the product's market reach and penetration, and bringing a leap forward in the precision management of DKD.