The Journey of Validation: From Bench Discovery to Clinical Guideline Recommendation
Forged through more than ten years of meticulous research and global validation, setting the gold standard in precision renal care.
2011-2017
Discovery & Translation
- Proprietary Technology：Discovered the novel biomarker, uPTM-FetA, utilizing advanced proteomics platforms.
- Initial Proof of Concept：Delivered global clinical trial testing services to major pharmaceutical companies, establishing preliminary clinical utility.
- Patent Strategy：Strategically established a comprehensive global intellectual property (IP) and patent portfolio for our core technologies.
- Assay Prototyping：Successfully translated scientific discoveries into an in vitro diagnostic (IVD) prototype with robust potential for clinical application.
2016-present
Clinical Validation
- Real-World Data (RWD) & Evidence：Executed multinational clinical studies, accumulating robust data from a diverse cohort of over 6,000 subjects.
- Multinational Clinical Validation：Collaborated with leading global medical centers, conclusively demonstrating DNlite's superior efficacy in the early prediction of renal function decline.
- High-Impact Peer-Reviewed Publications：Groundbreaking research outcomes published in authoritative international journals, including the American Journal of Nephrology (AJN), solidifying a rigorous scientific foundation.
2020-present
Regulatory Approval
- Pioneering EU IVDR Certification：Successfully achieved the stringent EU In Vitro Diagnostic Regulation (IVDR) certification, proudly marking it as the world's first renal prognostic test to attain this prestigious regulatory milestone.
- Global Market Authorizations：Secured regulatory clearances in over 41 countries, strategically expanding our footprint across regions with a high prevalence of Diabetic Kidney Disease (DKD), including Southeast Asia, the Middle East, and Latin America.
- Robust Quality Management System：Established a highly scalable manufacturing infrastructure fully compliant with ISO 13485 and rigorous IVDR QMS standards, guaranteeing a consistent and reliable global product supply.
2023-present
Guidelines & Adoption
- Landmark Achievement：Officially incorporated into the Taiwan Clinical Care Guidelines for Diabetic Kidney Disease, securing endorsement from major medical societies as a designated risk assessment tool.
- Standard of Care Integration：Widely adopted by frontline clinicians, seamlessly integrating into the routine clinical care pathways and treatment algorithms for patients with diabetes.
- Market Access & Reimbursement Expansion：Actively advancing inclusion in international clinical guidelines and securing national healthcare reimbursement coverage, ultimately establishing a new global standard in precision renal care.
2024-future
The Next Horizon
- Indication Expansion：Broadening clinical applications beyond diabetic kidney disease into non-diabetic (Non-DM) renal disease territories.
- Global Guideline Integration：Actively advocating for DNlite’s inclusion in major international clinical practice guidelines to establish a worldwide standard of care.
- Therapeutic Efficacy Biomarker：Establishing the test as a definitive biomarker for monitoring treatment response and evaluating therapeutic efficacy.
- Pipeline Diversification & Scaling：Developing novel diagnostic biomarkers across diverse therapeutic areas, successfully replicating the proven commercial and clinical model of DNlite.
