Shanghai Ruikang Biotech: IVD-Driven Integrated Solutions Pave the Way for Clinical Mass Spectrometry Adoption
“To Achieve Major Breakthroughs, Clinical Mass Spectrometry Must Build Comprehensive Product Solutions!“This is the profound insight Dr. Xie Xiaolei has gained after years of developing mass spectrometry applications.”
Dr. Xie Xiaolei is a global leader in clinical mass spectrometry and one of the earliest researchers in China to conduct mass spectrometry research. With 20 years of experience in mass spectrometry R&D, application, and market development, he previously led the global clinical mass spectrometry application team at Thermo Fisher Scientific in the United States, developing over 100 new methods for clinical mass spectrometry applications.
Upon returning to China, Xie Xiaolei began advocating for comprehensive clinical mass spectrometry solutions, a concept that aligns closely with Shanghai Reigncom Biotechnology Co., Ltd.’s goal of “commercializing mass spectrometry products” and its inherent focus on the IVD industry.
Shanghai Reigncom Biotechnology Co., Ltd. originally held 89 Class II and one Class III biochemical reagent kits, backed by robust IVD sales capabilities and distribution channels. As competition for traditional products intensified, the company shifted its focus toward more competitive, cutting-edge innovative products, targeting the clinical mass spectrometry market, which was then in its nascent stage. To this end, it actively recruited Dr. Xie Xiaolei to join as Chief Scientist, overseeing the research and development of mass spectrometry products.
As a key figure in the clinical mass spectrometry business of Shanghai Reigncom Biotechnology Co., Ltd., Dr. Xie Xiaolei has propelled the company to rapid prominence in the clinical mass spectrometry market. The company has established an international R&D and application team for clinical mass spectrometry reagent kits, developed a comprehensive portfolio of clinical mass spectrometry testing products, and provided customers with a series of integrated clinical mass spectrometry solutions. In 2021, the company completed a Series A financing round amounting to hundreds of millions of yuan, led by Matrix Partners China, with participation from Sinovation Ventures and Wosheng Investment.
What innovative approaches is Shanghai Reigncom Biotechnology Co., Ltd. taking to promote the widespread clinical adoption of mass spectrometry technology? Recently, VCBeat conducted an exclusive interview with Dr. Xie Xiaolei.
Previously, the industry may have been undecided between the IVD and LDT models, but in the past two years, IVD products have become mainstream, and a consensus has emerged within the industry regarding complete clinical mass spectrometry solutions.
Mass spectrometry is a sophisticated and complex technology. Mass spectrometers are classified as scientific instruments rather than devices specifically designed for clinical use. In clinical applications, they involve cumbersome workflows, complex sample pretreatment, numerous manual steps, low user-friendliness, and functional redundancy. Consequently, years of experience are typically required to achieve proficiency in operating mass spectrometers.
Clinical users differ significantly from research and industrial users. In China, clinical laboratories suffer from a severe shortage of relevant talent and lack the capacity to independently develop methodologies. A comprehensive solution, including automated pre-analytical systems, mass spectrometers, reagents, chromatography columns, and software, can lower the threshold for hospitals to implement mass spectrometry-based testing. Notably,A comprehensive solution is not a simple aggregation of these elements; to promote the clinical application of mass spectrometry, project-based holistic solutions are preferred.
Taking Shanghai Reigncom Biotechnology's 21-amino acid testing panel as an example,The company has integrated automated pre-treatment methods for 21 amino acid assays into its sample pre-processing instruments, with all parameters pre-optimized. Its 21-amino-acid detection kits are fully formulated, eliminating the need for hospitals to procure additional materials.
In terms of chromatography column consumables, the company has developed chromatography columns specifically dedicated to the detection of 21 types of amino acids according to project requirements; the instruments come with pre-built methodologies, and the software also includes built-in data processing methods, eliminating the need for further optimization based on the specific test items.
Each project from Shanghai Reigncom Biotechnology Co., Ltd. is configured differently and comes with a corresponding comprehensive solution. Therefore, no additional adjustments or preparations are required to implement mass spectrometry testing in clinical settings; staff can become proficient after just 2–3 days of training.
“This is equivalent to pre-prepared meals, which integrate all necessary main ingredients, auxiliary ingredients, and other components; they can be consumed after being heated in a microwave, with the taste remaining unchanged and the cooking difficulty significantly reduced,” stated Dr. Xie Xiaolei.
“But as everyone knows, the barrier to entry for comprehensive solutions is extremely high; it is not simply a matter of bundling instruments, reagents, and consumables for clinical use. On one hand, companies must adopt a project-driven approach to development; on the other, the product registration cycle is lengthy. Shanghai Reigncom Biotechnology Co., Ltd. adheres to the philosophy of undertaking difficult yet correct endeavors—paving roads through mountains and building bridges across rivers—to fully leverage the advantages of mass spectrometry through holistic solutions, thereby serving clinical laboratory testing.”
Shanghai Reigncom Biotechnology Co., Ltd. is convinced that comprehensive solutions represent the prevailing trend. Leveraging its strong heritage in the IVD industry, the company orientates its entire workflow—including instrument and reagent R&D, manufacturing, packaging, and quality control—toward IVD products. It has already established an end-to-end solution for clinical mass spectrometry.
In the pre-mass spectrometry sample preparation stage, current practices rely primarily on manual operations and lack standardization. Shanghai Reigncom Biotechnology Co., Ltd. has independently developedAUTOMAN Fully Automated Sample Processing System, accommodating sample preparation requirements for different reagent kits, significantly reducing the operational expertise required for mass spectrometry sample preparation.
In the field of mass spectrometry, Shanghai Reigncom Biotechnology Co., Ltd. partnered with Thermo Fisher Scientific in 2019 to jointly develop and manufacture products.RZ-500 Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry Detection System. With superior sensitivity, resolution, and scanning speed, the RZ-500 is suitable for detection in all mass spectrometry applications. For instance, its signal-to-noise ratio of 500,000:1 enables precise detection of low-concentration substances with high sensitivity requirements, such as testosterone and other hormones; its ultra-high resolution of 0.2 Da can accurately separate two substances with very close molecular weights, thereby eliminating interference; and its maximum scanning speed of 600 SRM per second delivers excellent performance in high-throughput applications requiring rapid analysis, such as drug toxicity screening.
In particular,Shanghai Reigncom Biotechnology Co., Ltd. remains committed to building differentiated advantages through its reagent offerings. The company’s strategy is to first identify projects with clear clinical value and compliant pricing structures, tailored to the specific characteristics and needs of hospitals. By leveraging reagents to drive instrument adoption, it aims to facilitate the efficient operation of mass spectrometry testing programs within hospital settings.
In terms of applications, mass spectrometry offers higher sensitivity and specificity, enabling multi-analyte detection. It is gradually replacing certain traditional biochemical and immunoassay tests in in vitro diagnostics and has opened up new market opportunities. Mass spectrometry demonstrates unparalleled advantages over conventional methodologies in areas such as newborn screening, therapeutic drug monitoring, hormone testing, and nutritional element analysis.
Shanghai Reigncom BiotechnologyFocusing on projects that fully leverage the advantages of mass spectrometry, we currently offer multiple exclusive products,Total T3, Total T4, folate, vanillylmandelic acid, and creatinine assays are the first kits approved in the industry. In addition to routine tests, the company is also developing high-end projects in the areas of microbial detection, infectious diseases, and oncology.
Furthermore, Dr. Xie Xiaolei believes that strengthened regulation of mass spectrometry kits is imperative. Shanghai Reigncom Biotechnology Co., Ltd. places high importance on product compliance and the development of its quality management system. Currently, the company holds six Class II mass spectrometry kit registrations, with several additional Class II kits expected to be approved in 2023.
An increasing number of companies in China are engaging in clinical mass spectrometry, driving growing market enthusiasm. Recently, IVD giant Roche Diagnostics announced its entry into the clinical mass spectrometry field, further propelling industry development. Shanghai Reigncom Biotechnology Co., Ltd. remains firmly optimistic about the prospects of China’s clinical mass spectrometry market. Moving forward, in addition to continuing the research and development of routine assays tailored to clinical needs, the company will place greater emphasis on developing innovative projects. By delivering comprehensive clinical mass spectrometry solutions led by reagent-based assays, Shanghai Reigncom aims to unlock the tremendous potential of the Chinese clinical mass spectrometry market.