ChenAn Bio's Flow Cytometry Mass Spectrometer Receives Medical Device Approval: The World's First from China, Ushering in a New Era of Single-Cell Precision Diagnostics

March 28, 2023,ChenAn Bio’s Polaris Starion M1.0 Mass Cytometer has officially received the Medical Device Registration Certificate from the Jiangsu Provincial Medical Products Administration (Registration No.: Su Xie Zhu Zhun 20232220387), becoming the world’s first mass cytometer approved for in vitro diagnostic use.It is an important milestone for mass cytometry technology to move towards clinical diagnosis and treatment.

Mass cytometry is a highly efficient and powerful analytical tool that integrates flow cytometry with mass spectrometry, enabling simultaneous multi-parameter detection at the single-cell level. Therefore, mass cytometry will undoubtedly advance the diagnostic technologies for hematologic diseases. ChenAn Bio’s mass cytometer has received market approval and obtained a medical device registration certificate, marking a milestone in the diagnosis of hematologic disorders. This achievement will further enhance the accuracy and speed of diagnosing hematologic diseases.

——Professor Wang Jianxiang (Deputy Director of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College)

The immunological mechanisms involved in the onset and progression of autoimmune diseases are highly complex, necessitating powerful tools for research and diagnosis. Mass cytometry (CyTOF) offers the advantage of simultaneously detecting multiple markers at the single-cell level, holding significant potential as an advanced research and diagnostic tool in clinical immunology. In particular, its ability to elucidate the pathogenesis of immune diseases at single-cell resolution will substantially advance the field of clinical immunology. The acquisition of a medical device registration certificate by ChenAn Bio’s mass cytometer represents a major achievement in the development of high-end domestically produced medical devices in China. This milestone sets a new benchmark for clinical diagnostic tools, and I look forward to leveraging mass cytometry to provide novel insights into the precision diagnosis and treatment of diseases in the future.

—Professor Zhu Ping (Chief Physician, Xijing Hospital of the Fourth Military Medical University; Director, Institute of Rheumatology, Chinese People's Liberation Army)

Mass cytometry is a high-performance analytical platform that integrates flow cytometry reagent methodology with mass spectrometry hardware technology. It utilizes antibodies labeled with mass tags and employs high-speed time-of-flight mass spectrometry to acquire high-resolution, high-sensitivity, and high-throughput data, thereby enabling multiparametric analysis of single cells or microspheres.

The product approved this time is Polaris Starion M1.0, which boasts leading performance and stability among similar products worldwide:

With a massive number of detection channels and globally leading sensitivity, it can easily achieveSingle Dose40 IndicatorsThe aforementioned single-cell high-dimensional analysis features no inter-channel interference and requires no color compensation.The development of the project is simple and rapid, easily achieving detection performance that surpasses existing methodologies.

After thorough validation through clinical trials,Demonstrates high concordance with existing methodological data for the same test items; features built-in internal standard calibration,Ensure stable and reliable quantitative results throughout the platform’s entire lifecycle. Features a simple, standardized workflow with one-click calibration; supports concurrent multi-user logins with role-based access control; and provides mature analysis templates tailored to diverse clinical application scenarios.

For multi-analyte application scenarios, there is no need to select fluorophores with specific excitation/emission wavelengths, nor is it necessary to perform multiple separate injections.Reagent Costs for Mass Cytometry Offer Significant Advantages Over Existing Methodologies；In addition, ChenAn Bio has developed a multi-sample barcoding technology that significantly reduces the complexity of sample pre-processing while further decreasing reagent consumption.

ChenAn Bio is dedicated to providing users with powerful and user-friendly single-cell solutions, offering high-resolution life science research tools and clinical diagnostic platforms through high-throughput single-cell omics technologies and advanced algorithms.