BOE Zhiwei Microbial Receives NMPA Approval for 30-Minute 'Gold Standard' Molecular POCT Platform

On August 2, 2022, the fully automated nucleic acid amplification analyzer (Model NAT-3000), independently developed and manufactured by Beijing BOE Microbial Technology Co., Ltd. (Genewise Bio), successfully obtained the Class III Medical Device Registration Certificate (No. Guo Xie Zhu Zhun 20223221029) from the National Medical Products Administration (NMPA). The approval of this product marks the official entry of domestic “gold standard” nucleic acid testing into a new era of 30-minute turnaround time.

Currently, conventional nucleic acid testing still requires transporting collected samples to specialized nucleic acid amplification laboratories for processing by trained personnel. Due to the multiple procedural steps and time-consuming nature of the testing process, combined with sample turnaround time, results typically take 6–12 hours to obtain. In response to scenarios requiring on-site, immediate testing and rapid result availability, the concept of molecular point-of-care testing (POCT) has emerged. Ideal molecular POCT products should feature integration, rapid detection, accurate results, and ease of operation. However, the highly complex workflow of “gold standard” nucleic acid testing imposes stringent requirements on product integration design and performance parameter optimization. A review of existing products in the Chinese market reveals that they either omit the nucleic acid extraction step or make trade-offs between temperature-cycling qPCR and isothermal amplification; thus, none fully meet the ideal characteristics of molecular POCT products.

Genewise Bio’s fully automated nucleic acid amplification analyzer (NAT-3000), a molecular POCT product independently developed across the entire chain, adheres to a design philosophy that integrates the “gold-standard methodology for clinical molecular diagnostics” with “engineering design of microfluidic chips.” Equipped with microfluidic reagent kits to form a closed system, it has achieved a breakthrough by requiring onlyOne StepSample Addition,30 Minutesimmediately atFully Enclosedof the kit, including “Magnetic Bead Method"Nucleic Acid Extraction" and "Quantitative Fluorescent PCR“Amplification”Gold Standard“Nucleic acidFastTesting.

Fully Enclosed

The kit adopts a fully enclosed microfluidic chip design, achieving "zero" aerosol contamination during the detection process;

Gold Standard

The kit integrates the entire testing workflow, from magnetic bead-based nucleic acid extraction to real-time fluorescent quantitative PCR amplification, meeting the clinical diagnostic “gold standard.”

30 Minutes

Upon loading the kit onto the instrument, data is interpreted in real time during the detection process; test results are available within 30 minutes, with support for early positive-result alerts.

High Sensitivity

Taking the “COVID-19/Influenza A/Influenza B Combo Test” kit as an example, the sensitivity can reach 200 copies/mL;

Simplified Operation

“Sample in, result out”: the entire testing process requires only a single sample loading step; 5 minutes of training, 1 minute to master operation.

Multi-sample Compatibility

Supports qualitative and quantitative detection of pathogenic microorganisms in various sample types, including throat swabs, sputum, and blood;

Module Composition

The device consists of a main system and subsystems, with each subsystem capable of simultaneously detecting four test kits (4 channels); one main system can be expanded to connect up to six subsystems at the same time.

Molecular POCT products are typical outcomes of the integration of medicine and engineering. From design and R&D to mass production and commercialization, they require interdisciplinary convergence across fluid dynamics, mechanical design, optics, physics, materials science, precision machining, embedded algorithms, electronic engineering, molecular biology, biochemistry, and industrial design. Adhering to its philosophy of “inclusiveness and breakthrough innovation,” Genewise Bio has overcome technical bottlenecks in multiple disciplines, achieving dual breakthroughs in both product performance and mass-production stability for its fully automated nucleic acid amplification analyzer (NAT-3000).

The fully automated nucleic acid amplification analyzer (NAT-3000) features rapid and simple operation with a high degree of integration, imposing minimal requirements on facility and personnel. It enables precise and rapid testing in a fully enclosed, portable, and automated instrument immediately after sample collection. The system is suitable for various scenarios, including fever clinics, emergency departments, disease control centers, screening and confirmatory testing for key populations, and customs inspection. It particularly meets the need for rapid testing during major public health emergencies and for urgent or special patient groups in medical institutions. Meanwhile, Genewise Bio has simultaneously developed a range of nucleic acid test kits targeting respiratory pathogens (such as combined detection of SARS-CoV-2, influenza A, and influenza B; Mycobacterium tuberculosis detection; non-tuberculous mycobacteria detection; and multiplex detection of multiple respiratory pathogens) and blood-borne pathogens (including HBV, HCV, and HIV).

In the future, Genewise Bio will continue to launch in vitro diagnostic solutions for maternal and child health, drug resistance genes, and tumor companion diagnostics, centered around its fully automated nucleic acid amplification analyzer (NAT-3000). This initiative aims to advance molecular diagnostic technology from single departments to multiple departments, from large hospitals to primary care institutions, and from limited applications to comprehensive scenarios.

As a Zhongguancun high-tech enterprise incubated by the BOE Group and specializing in molecular diagnostics, Beijing BOE Microbial Technology Co., Ltd. (Genewise Bio) adheres to its mission of “Molecular Diagnostics for Universal Benefit.” Focusing on the field of molecular testing, the company has established two innovative molecular POCT diagnostic technology platforms for clinical laboratory testing and home-based self-testing, and has undertaken multiple key R&D projects. The Genewise Bio team has filed over 80 patent applications to date and engages in scientific research and clinical translation collaborations with numerous renowned institutions. Committed to becoming a global leader in the molecular diagnostics industry, Genewise Bio empowers the development of China’s precision medicine system and tiered diagnosis and treatment framework through technological innovation.