BioMosaics' kidney disease test certified in over 40 countries; US commercialization to start Q3 driving growth
BioMosaics' kidney disease biomarker test has obtained certification in over 40 countries. US commercialization via LDT will begin in Q3, making this year the start of revenue growth.
📋 Article Processing Timeline
- 📰 Published: April 21, 2026 at 16:22
- 🔍 Collected: April 21, 2026 at 16:31 (9 min after Published)
- 🤖 AI Analyzed: April 21, 2026 at 21:42 (5h 10m after Collected)
(CNA Reporter Ho Hsiu-ling, Taipei, 21st) Tseng Tzu-ling, Chairperson of medical device company BioMosaics, stated that the company's proprietary kidney disease biomarker testing product has obtained certification in over 40 countries and continues to advance its regulatory and market access processes. The US market is expected to commercialize in the third quarter, contributing to revenue. This year marks the first year of revenue growth, and she holds a cautiously optimistic attitude towards operations.
BioMosaics held a media exchange meeting today. The company's proprietary in vitro diagnostic (IVD) reagent, DNlite-IVD103, indicated for predicting the risk of diabetic kidney disease (DKD) in type 2 diabetes patients, has obtained market approval in multiple EU countries, Taiwan, Malaysia, Thailand, Saudi Arabia, and the United Arab Emirates.
Tseng Tzu-ling pointed out that this year will be a crucial year for BioMosaics as it moves towards commercialization and scaled development, with market deployment focusing on two key markets: Taiwan and the United States.
Regarding Taiwan, she said DNlite has been included in the new "2024 Taiwan Clinical Care Guidelines for Diabetic Kidney Disease" as a clinical decision-making reference for monitoring kidney function. In the short term, the focus will be on grassroots clinics and health check-up centers, tapping into the demand for preventive medicine to help channels expand their customer base and improve retention rates. The medium-to-long-term plan is to apply for hospital self-pay codes and strive for inclusion in health insurance reimbursement to establish a stable growth foundation.
For the US market, they will simultaneously promote three major strategies: RUO (Research Use Only), LDT (Laboratory Developed Test), and IVD (In Vitro Diagnostic), gradually expanding DNlite's market influence and commercial value. Pushed by US distributors, DNlite will enter the US market in the LDT format. Currently, related product registration operations have been completed, and testing services are expected to launch in the third quarter of this year. In the short term, this is expected to bring cash flow and contribute to operations.
Looking at the shareholder structure, BioMosaics introduced the Anfu Health No. 2 Private Equity Fund at the end of 2024, holding about 15% of the shares and becoming the single largest shareholder. This fund is led by Lin Chun, Chairman of Anfu Capital. Lin Chun is also the Chairman of BRIM Biotechnology and SyneuRx International. (Editor: Yang Lan-hsuan) 1150421
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BioMosaics held a media exchange meeting today. The company's proprietary in vitro diagnostic (IVD) reagent, DNlite-IVD103, indicated for predicting the risk of diabetic kidney disease (DKD) in type 2 diabetes patients, has obtained market approval in multiple EU countries, Taiwan, Malaysia, Thailand, Saudi Arabia, and the United Arab Emirates.
Tseng Tzu-ling pointed out that this year will be a crucial year for BioMosaics as it moves towards commercialization and scaled development, with market deployment focusing on two key markets: Taiwan and the United States.
Regarding Taiwan, she said DNlite has been included in the new "2024 Taiwan Clinical Care Guidelines for Diabetic Kidney Disease" as a clinical decision-making reference for monitoring kidney function. In the short term, the focus will be on grassroots clinics and health check-up centers, tapping into the demand for preventive medicine to help channels expand their customer base and improve retention rates. The medium-to-long-term plan is to apply for hospital self-pay codes and strive for inclusion in health insurance reimbursement to establish a stable growth foundation.
For the US market, they will simultaneously promote three major strategies: RUO (Research Use Only), LDT (Laboratory Developed Test), and IVD (In Vitro Diagnostic), gradually expanding DNlite's market influence and commercial value. Pushed by US distributors, DNlite will enter the US market in the LDT format. Currently, related product registration operations have been completed, and testing services are expected to launch in the third quarter of this year. In the short term, this is expected to bring cash flow and contribute to operations.
Looking at the shareholder structure, BioMosaics introduced the Anfu Health No. 2 Private Equity Fund at the end of 2024, holding about 15% of the shares and becoming the single largest shareholder. This fund is led by Lin Chun, Chairman of Anfu Capital. Lin Chun is also the Chairman of BRIM Biotechnology and SyneuRx International. (Editor: Yang Lan-hsuan) 1150421
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The text, images, and audio/video on this website may not be reproduced, publicly broadcast, or publicly transmitted and utilized without authorization.