Bio Preventive Medicine Chairman Tzu-Ling Tseng stated on the 20th that the company's innovative kidney disease biomarker test kit, DNlite-IVD103, has been accelerating its overseas certifications since the second half of last year. Currently, it has obtained approvals in six countries worldwide, totaling seven marketing permits. Bio Preventive Medicine recently signed a memorandum of understanding (MOU) with AMG in Kuwait to jointly explore markets in ten countries in the Middle East and North Africa. The first batch of orders will be shipped in the second quarter.
Tzu-Ling Tseng said that Bio Preventive Medicine is currently deploying four strategies simultaneously for overseas market expansion. Firstly, DNlite-IVD103 has been approved for use in the European Union, Taiwan, Malaysia, Thailand, Saudi Arabia, and the United Arab Emirates. The company will continue to seek high-quality local distributors for cooperation. Secondly, Bio Preventive Medicine will accelerate sales channel development in Saudi Arabia and the United Arab Emirates. In Saudi Arabia, the focus will be on diabetic nephropathy and kidney transplant monitoring, while market development and sales in the United Arab Emirates have been entrusted to AMG.
Thirdly, Bio Preventive Medicine is striving to include DNlite-IVD103 in commercial insurance reimbursement in the Netherlands and Saudi Arabia. Fourthly, through its self-developed Laboratory Test Development (LTD) service, the company is positioning itself in the U.S. market. Ongoing discussions with potential partners are currently underway. The company is optimistic about its operational development in the next two years.
Bio Preventive Medicine stated that DNlite-IVD103 obtained market approval from the Taiwan Food and Drug Administration (TFDA) earlier this year, becoming Taiwan's first innovative diagnostic kit for precise prediction and management of diabetic kidney disease (DKD). To enhance promotion, the company will host a lunch meeting titled "Innovative Diagnostic Solution for Precision Management of DKD and Beyond" at the Taiwan Endocrine and Diabetes Society Symposium on March 23rd to 24th. The meeting will be chaired by Dr. Chien-Ning Huang, Chairman of the Taiwan Diabetes Society, and presentations will be given by Dr. Lee-Ming Chuang from National Taiwan University Hospital and Prof. Dr. Stephen Bakker, a kidney transplant authority from the Netherlands. They will share the results of long-term follow-up studies and their clinical experiences with DNlite-IVD103 to expand awareness of using biomarkers as preventive guidelines for disease care and increase exposure for DNlite-IVD103.
Tzu-Ling Tseng pointed out that there are currently over 90,000 dialysis patients in Taiwan, with poorly controlled diabetic nephropathy being a major cause behind the country's reputation as the "dialysis kingdom." Statistics show that about half of dialysis patients are caused by diabetic nephropathy. Effective and precise prevention and monitoring could help prevent rapid disease progression.
DNlite-IVD103, validated through multiple international verifications, can effectively predict and monitor the risk of type 2 diabetic nephropathy. Through this lunch meeting, the two authoritative physicians who personally lead the clinical use of DNlite-IVD103, together with domestic diabetes and nephrology physicians, aim to achieve zero-distance communication and further promote DNlite-IVD103.
In the Taiwanese market, Bio Preventive Medicine is actively collaborating with key opinion leaders (KOLs) and participating in national projects to include DNlite-IVD103 in the DKD prevention guidelines. Among them, in the government-established "Future Medical Laboratory 2.0" to establish a chronic kidney disease care ecosystem, Bio Preventive Medicine has taken the lead and jointly promoted chronic kidney disease care with AstraZeneca Taiwan and the Taiwan Society of Nephrology to screen high-risk groups for early detection and intervention, reducing disease progression and even the risk of dialysis.
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