UltraDx Receives First Clinical Approval of Single-Molecule Analyzer in China

UltraDx Receives First Clinical Approval of Single-Molecule Analyzer in China

By, Admin 6 September 2024

Overview

UltraDx Bio has announced that its flagship product, the UD-X Fully Automated Single-Molecule Array Fluorescence Immunoassay Analyzer, has received its first clinical registration approval in China.

Achievement Registered in NMPA

  • This groundbreaking achievement is now officially listed on the National Medical Products Administration (NMPA) website and marks a significant milestone in the field of medical diagnostics. 
  • The UD-X Single-Molecule Analyzer is designed for the ultra-sensitive detection and quantification of trace protein biomarkers in body fluids, reaching sensitivity levels at the fg/ml scale. 
  • This technology will be utilised alongside soon-to-be-approved companion assay kits, addressing the precision detection needs of clinical diagnostics and community health screenings.

UD-X Single-Molecule Analyzer

  • The successful approval and clinical deployment of the UD-X Single-Molecule Analyzer are poised to revolutionise early screening, early diagnosis, companion diagnosis and treatment effectiveness evaluation for diseases such as Alzheimer's Disease (AD). 
  • This advancement is not only of immense clinical value but also holds significant social and economic importance.

Simoa Single-Molecule Array Technology

  • The company's products leverage state-of-the-art Simoa single-molecule array technology, adapted and approved for clinical use in China. 
  • With comprehensive capabilities in R&D, translational research, production, clinical registration, and quality management, UltraDx Bio focuses on developing diagnostic tools for neurological, infectious, immune, cardiovascular, and tumor diseases. 
  • The company operates R&D and production centres in Shanghai and Shijiazhuang, offering a robust product portfolio that includes AD early diagnostic instruments, reagents, and complete service solutions.

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