NEW YORK – Chinese life science firm UltraDx Bio said Wednesday that it has received Chinese clinical registration approval for its UD-X Fully Automated Single-Molecule Array Fluorescence Immunoassay Analyzer.
With the approval, the UD-X analyzer, which uses Quanterix's single-molecule array technology for highly sensitive immunoassay measurements, can be used for clinical applications in China.
UltraDx said it plans to use the analyzer for running assays targeting disease including Alzheimer's disease where highly sensitive measurements can aid screening, early diagnosis, and treatment monitoring.
“We are very excited and confident about using Simoa for early diagnosis of [Alzheimer's] and other diseases in China," Keith Crandall, cofounder and managing director of ARCH Venture Partners, an investor in UltraDx, said in a statement. "We are fully committed to investing funds and resources to translate this breakthrough technology into products and solutions for research and diagnostics to help patients and their families around the world."
"Our collaboration with UltraDx Bio for IVD product development and commercialization in China will accelerate and improve early diagnosis of Alzheimer's disease patients,” Quanterix CEO Masoud Toloue said in a statement. "We’re excited about the IVD achievement and a look forward to supporting UltraDx in broadening early Alzheimer’s disease testing in China."