UltraDx Bio has announced that its UD-X™ Fully Automated Single-Molecule Array Fluorescence Immunoassay Analyzer has received clinical registration approval from China's National Medical Products Administration (NMPA). This approval marks a significant step forward in the early detection and diagnosis of diseases, particularly Alzheimer's Disease (AD). The UD-X™ analyzer is designed for the ultra-sensitive detection and quantification of trace protein biomarkers in body fluids, achieving sensitivity levels at the fg/mL scale.
Revolutionizing Early Disease Detection
The clinical deployment of the UD-X™ Single-Molecule Analyzer is expected to revolutionize early screening, diagnosis, companion diagnostics, and treatment effectiveness evaluation for diseases like Alzheimer’s. Alzheimer's disease is a growing concern in China, which has the highest number of affected individuals globally. The economic burden associated with Alzheimer’s in China is projected to reach nearly one trillion yuan by 2030. Early and accurate diagnosis is crucial for effective intervention and treatment.
Expert Endorsements and Clinical Significance
At the launch ceremony for the UD-X™ analyzer, key opinion leaders and scientists emphasized the importance of early detection for diseases like Alzheimer's. Academician George Fu Gao highlighted that precision diagnosis is the cornerstone of precision medicine, praising UltraDx Bio’s efforts in developing advanced diagnostic tools for Alzheimer’s disease. Professor Jintai Yu, of the National Clinical Center for Neurological Diseases in Shanghai, stressed that early detection and intervention are crucial to slow down the progression of the disease, pointing to the potential of plasma biomarker precision testing as a solution for large-scale diagnostic needs.
Technology and Future Applications
The UD-X™ analyzer utilizes single-molecule array technology to detect trace protein biomarkers in body fluids. This technology will be used alongside companion assay kits to address the precision detection needs of clinical diagnostics and community health screenings. According to Dr. Masoud Toloue, CEO of Quanterix, the collaboration with UltraDx Bio for IVD product development and commercialization in China will accelerate and improve early diagnosis of Alzheimer’s disease patients.
UltraDx Bio's Commitment
UltraDx Bio, founded by Jay Dong, is dedicated to enhancing its R&D and production capabilities. The company is committed to fostering collaborations with various stakeholders to promote continuous advancements in disease screening, precision diagnostics, and the development of versatile application platforms. Jay Dong, CEO of UltraDx, stated that this approval is "only a small step towards achieving a great mission: enabling early diagnosis and early intervention, and making our world a healthier planet."
