AstraBio's First Fully Automated Fluorescence Immunoassay Analyzer Based on Single-Molecule Analysis Strategy Receives Class II Medical Device Approval

June 20, 2022, Suzhou Yuce Biotechnology Co., Ltd.'s core technology productBased on Single-Molecule Analysis StrategiesThe fully automated fluorescence immunoassay analyzer Dx-90 has obtainedJiangsu Provincial Medical Products AdministrationApproved Registration Certificate for Class II Medical Devices (Su Xie Zhu Zhun 20222221358). The approval of Dx-90 underscores Yuce Biotech’s substantial leading advantage in the field of high-sensitivity immunoassays, and signals that the company will achieve a complete closed-loop business model in the “industry-academia-research-clinical” translation of high-sensitivity detection for novel biomarkers.

Suzhou Yuce Biotechnology Co., Ltd. is one of the few high-tech enterprises that have achieved the industrialization of single-molecule immunoassay technology, with its core technologies possessing fully independent intellectual property rights. Compared with traditional immunoassay techniques, Yuce Biotechnology’s single-molecule immunoassay technology breaks through the bottlenecks of conventional methods by leveraging ultra-high molecular signal recognition resolution and a digital single-molecule quantification strategy, achieving an approximately 1,000-fold increase in sensitivity. The company’s high-throughput, fully automated, and highly sensitive single-molecule immunoassay platform enables the clinical application of more than a thousand low-abundance biomarkers.

To date, Yuce Bio has established a novel “industry-academia-research-clinical” biomarker translation platform. By integrating an open semi-automated single-molecule immunoassay system with a fully automated single-molecule immunodiagnostic system, the company provides a comprehensive solution spanning initial biomarker screening, core biomarker kit development, and clinical translation of single-molecule immunoassay products. With a fully open approach to the research and clinical translation of novel biomarkers, Yuce Bio aims to thoroughly resolve the critical bottlenecks hindering the clinical translation of new biomarkers.

The company adheres to the principle of “Empowering Human Health Through Precision Testing, Creating an Infinite Future Through Technological Innovation” innovative concept, leveragingSolidscientific research capabilities and innovative technologies, continuouslyR&DCompetitive Products,Tight GripCustomer Requirements,Leading the way in China's single-molecule immunoassay diagnostics sector.