BPM Showcases DNlite-IVD103 at MEDICA 2023, Accelerating European Expansion Following Major Clinical Validations

World-First Innovation with Extensive Clinical Backing

DNlite-IVD103 is the world's first Enzyme-Linked Immunosorbent Assay (ELISA) test designed to prevent the rapid progression of Diabetic Kidney Disease. To date, it has accumulated clinical research involving over 2,000 patient samples. Its indications cover Type 1 and Type 2 Diabetic Kidney Disease (DKD), Acute Kidney Disease (AKD), and kidney transplant monitoring.

DNlite-IVD103 obtained the CE-IVD mark in the European Union in 2020, making Europe its first commercial market. Although market promotion was temporarily interrupted by the pandemic, continuous clinical validation has enabled the product to successfully penetrate major European medical centers and garner the strong support of KOLs.

Independent Validation by Top European Experts

At the European Association for the Study of Diabetes (EASD 2023) Annual Meeting held in early October, an independent research team from the University of Pisa (Università di Pisa, UNIPI), Italy, was invited to deliver an oral presentation titled "Clinical Outcomes and Biomarkers in Diabetic Kidney Disease." The biomarker utilized in this study was DNlite-IVD103, and the results yielded positive validation: DNlite-IVD103 accurately prevents and monitors DKD in Type 2 diabetes. 

Chairman Tseng emphasized that this study was an independent clinical validation, with the research team purchasing DNlite-IVD103 directly from local distributors. The seven co-authors of the presentation are all leading experts in the fields of diabetes and metabolism. Among them, Dr. Stefano Del Prato is a Professor of Endocrinology and Metabolism at the University of Pisa School of Medicine and Director of the Diabetes Section at the University Hospital of Pisa. He is also a prominent member of the American Diabetes Association (ADA) and the current President of the EASD. Earning the recognition of Professor Del Prato holds extraordinary significance for the clinical value of DNlite-IVD103.

Top-Tier Journal Publications and Regulatory Milestones

Following the EASD annual meeting, the world's first multinational, cross-ethnic long-term clinical validation of DNlite-IVD103—integrating data from Taiwan and Europe—was selected for publication in the top-tier, peer-reviewed American Journal of Nephrology (AJN), earning recognition from the medical community in the United States, the world's largest pharmaceutical market. Subsequently, clinical validation results for DNlite-IVD103’s application in kidney transplantation were also published in the latest issue of AJN, demonstrating that the biomarker serves as an effective indicator for early prognostic renal function assessment in kidney transplant recipients (KTR).

Simultaneously, the Thai FDA recently granted marketing authorization for DNlite-IVD103 with the indication for prognostic risk assessment of renal function in kidney transplant patients, making Thailand the first country globally to approve the DNlite kidney transplant application for commercial sale. 

 Furthermore, at the ASN Kidney Week in early November, a study examining the correlation between DNlite-IVD103 and Coronary Artery Disease (CAD) was presented for the first time. This continuous stream of international research publications clearly indicates the immense potential of DNlite-IVD103 for developing new clinical applications.

Strengthening the European Distribution Network

Chairman Tseng pointed out that clinical validation is paramount for the market promotion of innovative medical products. Having successfully gained recognition and endorsement from authoritative medical institutions in Europe and the U.S., DNlite-IVD103 is poised for a significant boost in brand awareness and trust.

Currently, BPM is actively refining its European distribution deployment. The company recently signed an agreement with Netherlands-based Bio-Connect, granting them exclusive distribution rights in the Benelux region and non-exclusive rights in select European areas. During her current tour, Chairman Tseng will hold further discussions with Bio-Connect on marketing and sales strategies. Concurrently, BPM plans to initiate a new round of clinical validation projects in the Netherlands, specifically targeting correlation studies with Cardiovascular Disease (CVD) complications, to continuously expand the indications of DNlite-IVD103 and elevate its overarching economic value.