[Regulatory Milestone] BPM’s DNlite-IVD103 Successfully Achieves EU IVDR Certification, Accelerating Global Market Expansion

Bio Preventive Medicine Corp. ("BPM", Stock Code: 6810) announced today (30th) that its flagship product, DNlite-IVD103, has successfully obtained the European Union's IVDR certification. It is the first product in Taiwan to receive IVDR certification from BSI (British Standards Institution) under the new EU regulations, and the world's first innovative diagnostic product in the field of precision kidney function management to achieve this rigorous certification.

DNlite-IVD103 previously held the CE-IVD mark. An upgraded version was submitted for the new IVDR application, successfully securing the new EU certification and completing the transition from the legacy IVDD framework. Furthermore, its indications have been expanded from the prognostic risk assessment of Diabetic Kidney Disease (DKD) in Type 2 diabetes patients to include the prognosis of kidney transplant (KT) patients. Securing these two indications simultaneously not only proves that the product's safety and efficacy meet stringent evaluation requirements but also accelerates the promotion of DNlite-IVD103, further consolidating its leading position in the European market.

BPM pointed out that the "CE" mark is a mandatory certification for the EU; In Vitro Diagnostic (IVD) medical devices must obtain CE certification before entering the European market. Under the previous EU In Vitro Diagnostic Directive (IVDD), nearly 90% of products could be marketed through self-declaration. However, since the new In Vitro Diagnostic Regulation (IVDR) replaced the IVDD, significantly stricter requirements have been imposed on technical documentation, clinical evaluation, and post-market surveillance. It is estimated that 90% of products must now submit a conformity assessment procedure to a Notified Body to ensure compliance with IVDR requirements and obtain a CE certificate prior to market launch. Failure to do so will result in an inability to promote or forced market withdrawal after the transition period, quietly initiating a new round of industry shakeouts.

DNlite-IVD103 is an innovative kidney disease biomarker test independently developed by BPM. Applied to DKD risk assessment, it can predict and monitor the deterioration of a patient's kidney function over the next 5 years, compensating for the clinical shortcomings of current Urinary Albumin-to-Creatinine Ratio (UACR) and estimated Glomerular Filtration Rate (eGFR) tests. When applied to the prognostic monitoring of kidney transplant patients, its accuracy in predicting renal graft failure exceeds 90%. Whether for DKD or kidney transplantation, DNlite-IVD103 effectively achieves precision care and management of the disease.

According to data from the International Diabetes Federation (IDF), estimating across 59 countries and territories in the European region, the diabetic population reached 61 million in 2021, with related healthcare expenditures soaring to $189.3 billion USD—accounting for nearly 20% of global healthcare costs. Consequently, nations are dedicated to improving current disease care and management to alleviate this immense medical burden.

In addition, Spain, France, and the Netherlands rank among the top five countries globally with the highest rates of kidney transplantation. Clinical data shows that half of kidney transplant patients will experience graft failure within 10 years, facing life-threatening risks. Therefore, more frequent testing is imperative, presenting a highly definitive and substantial market opportunity for DNlite-IVD103. 

Dr. Karen Tseng, Chairman and CEO of BPM, further stated that the company has adopted a localized network marketing model in the European market by collaborating with Key Opinion Leaders (KOLs). BPM has completed distribution licensing in multiple EU countries and regions, is in continuous discussions with local insurance institutions, and is executing several healthcare programs in the Netherlands. Obtaining the EU IVDR certificate for dual indications will accelerate the rollout of subsequent clinical applications and further enhance the opportunity to incorporate DNlite-IVD103 into global clinical care and treatment guidelines, bringing positive and long-term benefits to the company's future operational growth.   

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