Bio Preventive Medicine (BPM; stock code: 6810) announced today (September 30th, 2024) that its main product, DNlite-IVD103, has received EU IVDR certification. This marks the first EU IVDR certification issued by BSI in Taiwan. DNlite-IVD103 is also the first innovative IVD product globally to receive an IVDR certification in the precision management of kidney health.
DNlite-IVD103 was authorized to market in EU previously under IVDD as a CE-marked general IVD product. With the more stringent regulation requirements under IVDR, DNlite-IVD103 has successfully received EU IVDR certification for its improved version as a Class B IVD device. The indication of DNlite-IVD103 has been expanded from type 2 diabetes (DKD) patients to include kidney transplant patients for kidney function prognosis, achieving approval for both indications at once. This achievement not only demonstrates that the safety and efficacy of DNlite-IVD103 meets a high standard, but also facilitates the promotion of DNlite-IVD103 and strengthens its leading position in the European market.
BPM notes that the CE mark is a mandatory certification process in EU for In vitro diagnostics (IVDs) device before entering the European market. Under the previous IVDD regulations, nearly 90% of the IVD products could be self-declared for market entry. However, with the new IVDR regulations replacing IVDD, there are stricter requirements for technical documentation, clinical evaluation, and post-market surveillance. It is estimated that 90% of the IVD products will now need to undergo a conformity assessment procedure with a notified body to confirm compliance with IVDR and receive a CE certificate before they can be marketed. If not, these products cannot remain on the EU market after the transition period. A new round of market share battle has begun.
DNlite-IVD103 is a product with an innovative kidney disease biomarker independently developed by BPM for risk assessment of kidney function in patients with DKD or kidney transplant. In addition to measurement in current urinary albumin (UACR) and estimated glomerular filtration rate (eGFR), DNlite-IVD103 provides additional prognosis information for DKD patients over the next five years. Whether for DKD or kidney transplantation, DNlite-IVD103 can effectively enhance precision management of kidney health for patients.
According to the International Diabetes Federation (IDF), it is estimated that 61 million people had diabetes in the 59 EU countries and regions in 2021, with related healthcare costs reaching $189.3 billion, accounting for nearly 20% of global healthcare expenditures. Many countries are committed to improving disease care and management to reduce the healthcare burden.
Moreover, Spain, France, and the Netherlands are among the top five countries globally with the highest kidney transplant rates. Clinical data shows that half of the kidney transplant patients experience kidney failure within ten years, posing a mortality threat; therefore, effective prognosis and frequent monitoring are necessary for these patients. This represents a critical user need for DNlite-IVD103.
BPM CEO, Tseng Tzu-Ling, stated that the company has adopted a regional marketing model in the Europe through partnerships with opinion leaders. It has completed distribution authorizations in multiple EU countries and continues discussions with local insurance institutions while executing several healthcare initiatives in the Netherlands. The recent dual-indication EU IVDR certification for DNlite-IVD103 will accelerate the advancement of various clinical applications and enhance opportunities for integrating DNlite-IVD103 into clinical care and treatment guidelines, positively impacting the company's future operational development.