BPM (6810): DNlite-IVD103 Included in 2024 Taiwan Clinical Practice Guidelines for Diabetic Kidney Disease

BPM (6810) announced on the 17th that the newly released 2024 Taiwan Clinical Practice Guideline for Diabetic Kidney Disease officially recommends the use of DNlite-IVD103—developed by BPM—as an indicator for predicting renal function deterioration in patients with type 2 diabetes. This offers physicians a valuable tool for early detection and the formulation of personalized treatment strategies.

According to BPM, this marks the first time an innovative biomarker diagnostic tool developed independently in Taiwan has been included in such guidelines. It is expected to reshape the prevention, treatment, and co-management of diabetic kidney disease (DKD), moving the healthcare system toward a more personalized and precision-based model. As DNlite-IVD103 continues to be adopted in clinical settings, it is anticipated to make a significant contribution to the company’s operational growth.

The 2024 Taiwan Clinical Practice Guideline for Diabetic Kidney Disease was led and published by the Diabetes Association of the Republic of China (Taiwan). The guidelines aim to integrate the latest clinical research findings and expert consensus to provide healthcare professionals with a scientific and systematic care framework for more effective DKD management. As this is the first update in five years, the new edition notably recommends incorporating personalized risk prediction tools into the existing disease classification system to enhance individualized care for DKD patients in Taiwan.

The updated guidelines clearly state that DNlite-IVD103, developed locally in Taiwan, has been clinically proven to predict renal function decline in patients with type 2 diabetes. By identifying high-risk individuals early through personalized risk prediction tools, it offers a valuable opportunity for timely intervention and proactive treatment, helping to prevent progression to end-stage kidney disease and reduce the burden on families and society.

DNlite-IVD103 is the world’s first ELISA-based diagnostic kit designed to prevent rapid progression of DKD. It has received marketing approvals in multiple countries and has been validated through various studies. DNlite-IVD103 offers robust detection capabilities for early-stage prevention and monitoring of renal function. It effectively complements existing tests such as urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR), enabling comprehensive kidney disease management for diabetes patients. It is also applicable in monitoring post-kidney transplant prognosis.

BPM CEO Dr. Tseng Tzu-Ling stated that the latest KDIGO 2024 guidelines—published by KDIGO, the world’s leading kidney health organization—also recommend the use of personalized risk prediction tools as a clinical decision aid for enhanced renal monitoring. The inclusion of DNlite-IVD103 in Taiwan’s new DKD guidelines represents a significant recognition of the company’s innovation and provides physicians, patients, and caregivers with a reliable resource for disease prevention and treatment.

BPM plans to first apply for DNlite-IVD103 to be offered as a self-paid test item and will actively promote it across diagnostic labs, public health bureaus, local clinics, and hospitals. The company is also working to include the test under national health insurance reimbursement in the near future.

Taiwan has more than two million people living with diabetes. Once DNlite-IVD103 becomes a routine tool, it is expected to be used one to two times per year for disease monitoring and prevention, providing the company with a stable, long-term revenue stream.

Dr. Tseng also noted that the certification process for DNlite-IVD103 continues to progress. In 2024 alone, the test has received additional approvals in Turkey and Mexico. Globally, DNlite-IVD103 is now approved in Malaysia, Thailand, Saudi Arabia, Taiwan, the United Arab Emirates, Vietnam, Indonesia, Guatemala, Brazil, Singapore, the European Union (under the new IVDR regulation), and Australia. Its approved indications include risk assessment for DKD in type 2 diabetes patients, as well as renal function monitoring in kidney transplant (KT) recipients. As biomarker-based risk assessment becomes a growing trend in DKD management, the company aims to establish DNlite-IVD103 as a global benchmark in clinical guidelines—ultimately benefiting patients worldwide.