UltraDx Bio has secured clinical registration approval for its UD-X fully automated single-molecule array fluorescence immunoassay analyser in China.
This device is now officially listed on the National Medical Products Administration (NMPA) site.
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The analyser is specifically designed for the ultra-sensitive detection of trace protein biomarkers in body fluids, boasting sensitivity levels at the fg/ml scale.
The technology is expected to be used in conjunction with companion assay kits, which are awaiting approval, to meet the precision detection requirements of clinical diagnostics and community health screenings.
UltraDx Bio expects the approval of the UD-X analyser to transform early screening, diagnosis, and treatment assessment for diseases such as Alzheimer’s disease, offering significant clinical, social, and economic benefits.
Last month, UltraDx Bio launched the UD-X analyser for disease detection and management.
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By GlobalDataUltraDx CEO Jay Dong said: “This is only a small step towards achieving a great mission: enabling early diagnosis and early intervention, and making our world a healthier planet.”
The company is supported by biopharmaceutical venture capital funds including GF HK and ARCH.
UltraDx Bio’s offerings utilise the advanced Simoa single-molecule array technology, which has been adapted and approved for clinical use in China.
The Simoa-based clinical tests that are developed by the company enable precise and early diagnosis for intervention as well as treatment.
GF Hong Kong managing director Xiaoying Mai said: “GFHK fully supports this company that can provide a solution to the huge blue ocean market of early Alzheimer’s disease diagnosis and hopes that patients will soon benefit from this technology.”
