BPM’s DNlite-IVD103 Receives TFDA Class III Approval, Becoming Taiwan’s First Precision Diagnostic for Diabetic Kidney Disease

Bio Preventive Medicine Corp. ("BPM", Stock Code: 6810) announced that on January 3, 2024, it received official notification from the Taiwan Food and Drug Administration (TFDA) granting Class III In Vitro Diagnostic (IVD) marketing authorization for its proprietary ELISA kit, DNlite-IVD103. This milestone marks the approval of Taiwan’s first innovative diagnostic test dedicated to the precision prediction and management of Diabetic Kidney Disease (DKD).

Transforming the DKD Care Paradigm in Taiwan 

Over half of the new dialysis patients in Taiwan each year are a direct result of poorly controlled diabetes. The launch of DNlite-IVD103 will introduce a novel co-management model for the more than 2.4 million diabetic patients in Taiwan, helping to elevate healthcare quality and reduce overall medical costs. 

DNlite-IVD103 has already secured IVD market authorizations in the EU, Malaysia, Thailand, and Saudi Arabia for preventing rapid renal decline in Type 2 diabetes patients. Through the non-invasive detection of specific urinary biomarkers, it effectively predicts and monitors the deterioration of a patient's kidney function over the next 5 years. Crucially, its predictive power is independent of conventional clinical risk indicators such as albuminuria (UACR) and estimated Glomerular Filtration Rate (eGFR). Based on the DNlite-IVD103 risk stratification assessment, a comprehensive report featuring recommended monitoring frequencies and care directions will be generated to assist physicians in clinical decision-making.       

A Three-Pronged Commercialization Strategy 

Dr. Karen Tseng, Chairman and CEO of BPM, stated that following the global clinical validation of DNlite-IVD103—highlighted by the publication of a long-term cross-regional cohort study integrating data from Taiwan and Europe in the American Journal of Nephrology (AJN)—this TFDA approval is another monumental achievement. Moving forward, BPM will implement a three-pronged strategy to accelerate market penetration in Taiwan and swiftly drive revenue momentum:   

1. Clinical Channel Expansion: BPM will aggressively collaborate with major hospitals and health checkup centers to expand out-of-pocket health screening channels. 
2. Innovative Insurance Partnerships: The company is planning to partner with insurance companies to launch health-linked "spillover-effect" insurance policies, promoting the concept of  proactive preventive health management among the public. 
3. Routine Screening & Guidelines: BPM will continue to advocate for the inclusion of DNlite-IVD103 in routine diabetic screenings to bridge the current gap in DKD prevention and diagnosis, aiming to establish it as a new standard in clinical care and treatment guidelines.         

Alleviating a Massive Financial Healthcare Burden 

Statistics show that approximately 1 in 10 people in Taiwan has diabetes, and Type 2 diabetes is trending younger due to evolving dietary habits. Furthermore, the number of dialysis patients resulting from renal failure continues to rise, with over half stemming from poorly managed diabetes. According to Taiwan's National Health Insurance Administration (NHIA), Acute/Chronic Kidney Disease and Diabetes ranked as the first and third most expensive diseases in 2022, consuming NT$58.7 billion and NT$40.2 billion in medical expenditures, respectively. Integrating DNlite-IVD103 into routine diabetes care for early prevention and treatment will not only significantly alleviate the government's heavy financial burden but also help construct an innovative, precision health management system to benefit a vast number of patients.

The international medical community is increasingly advocating for the use of biomarker testing to improve the current DKD care paradigm, with growing discussions around revising global clinical care and treatment guidelines. Even the U.S. FDA has begun to address the fact that current DKD care guidelines fail to meet patient needs. Once biomarker IVDs become the new global gold standard for precision DKD testing, it will drastically improve disease care for nearly 540 million diabetic patients worldwide and propel BPM into a new era of operational growth. 

Optimistic Global Outlook and Indication Expansion 

DNlite-IVD103 is a pioneering diagnostic reagent for precision DKD management, leading international peers by securing early market approval in the EU. Since the launch of the upgraded DNlite-IVD103, it has successfully gained approvals in Thailand, Saudi Arabia, and Taiwan. Moreover, BPM has successfully expanded its indications in Thailand and Saudi Arabia to include risk assessment for prognostic renal graft failure in Kidney Transplant (KT) patients. With multiple regulatory applications currently under review in other countries and anticipated approvals on the horizon, BPM remains highly optimistic about its operational performance this year.