UltraDx Gains First Clinical Approval for Single-Molecule Analyzer in China

UltraDx Gains First Clinical Approval for Single-Molecule Analyzer in China

By, Admin 9 September 2024

Overview

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

About UD-X™ Analyze

  • The UD-X™ Analyzer is designed to detect and measure trace amounts of protein biomarkers in body fluids with high sensitivity, at levels as low as fg/ml. 
  • It will be used with companion assay kits, soon to be approved, to meet the precision detection needs in clinical diagnostics and community health screenings.

Approval for UD-X™ Analyzer

The approval and clinical rollout of the UD-X™ Analyzer is set to transform early screening, diagnosis, and treatment effectiveness assessments for diseases such as Alzheimer's. 

This breakthrough not only has important clinical value but also offers social and economic benefits.

Alzheimer's Disease

  • Alzheimer's disease, the most common age-related neurodegenerative condition, affects millions of people in China. 
  • With over ten million patients, China has the highest number of Alzheimer's sufferers globally. 

Economic impact of Alzheimer by 2030

  • By 2030, the economic impact of Alzheimer's in the country is expected to approach one trillion yuan. 
  • UltraDx Bio's Simoa®-based clinical tests provide a timely and effective solution, enabling earlier and more accurate diagnosis for better intervention and treatment.

Listing in NMPA

  • he product is now officially listed on the National Medical Products Administration (NMPA) website (Registration Certificate No.: JXZZ 20242220334). 
  • This marks a major step forward in the field of medical diagnostics. 

About UltraDx Bio

  • UltraDx Bio is dedicated to innovation and improving patient care. 
  • The company will continue to invest in research, development, and production capabilities, while working with partners to drive advancements in disease screening, precision diagnostics, and application platforms. 
  • The goal is to support industry growth and enhance global health outcomes.

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