[Dual Certification] QingYuan KaiWu's Integrated Sample Preparation Solution Bridges the Last Mile for NGS Hospital Implementation

QingYuan KaiWu, a Chinese biotechnology company specializing in next-generation sequencing (NGS) sample preparation equipment, has achieved a significant milestone with the dual certification of its core products. The company's EosBot® Seq24 Fully Automated Library Preparation Workstation has obtained Class II Medical Device Registration Certificate from China's National Medical Products Administration (NMPA), completing the full-chain medical device certification for its sequencing sample preparation product line.

This certification marks the official commercial launch of QingYuan KaiWu's "Fragmentation-Building Integration" sample preparation solution for clinical applications across hospitals and third-party medical laboratories in China, offering a 100% domestically produced compliant solution for the precision medicine industry.

Breaking the Import Dependency

Sequencing technology has become indispensable in precision medicine, widely applied in critical clinical scenarios including tumor precision diagnosis and treatment, genetic disease screening, and infectious pathogen detection. Sample preparation, as the source key process in sequencing detection, directly determines the reliability of sequencing data.

For years, China's clinical sequencing sample preparation market has been highly dependent on imported equipment. This reliance has resulted in high equipment procurement costs, monopolized proprietary consumables leading to elevated per-sample testing costs, poor equipment system compatibility, cumbersome operations, and insufficient automation reliability. These factors have significantly constrained the widespread implementation of clinical sequencing projects.

As regulatory frameworks continue to improve, NMPA has strengthened standardized and refined supervision of IVD and clinical sequencing applications. Equipment without medical device certification can no longer meet the core requirements for compliant clinical project implementation. The industry urgently needs an independent, controllable, compliant, efficient, and stable domestic sequencing sample preparation solution to ensure sequencing projects can truly be implemented in hospital settings.

The Integrated Solution

QingYuan KaiWu's "Sequencing Sample Preparation Automation Platform (NGS-APW)" precisely addresses this industry need. Centered on "precise fragmentation and automated library preparation," the platform delivers a fully certified, comprehensive, and integrated solution.

Sample Fragmentation: The EoSonics® FRAG Ultrasonic Focused Fragmentation Instrument series employs ACU™ Adaptive Cylindrical Ultrasonic technology. Using physical ultrasonic shearing, it effectively overcomes the drawbacks of traditional enzymatic methods. The system supports standard laboratory consumables including 8-tube strips and 96-well plates, eliminating the need for frequent plate transfers and achieving full coverage of 1-96 throughput, meeting mid-to-high throughput clinical compliance requirements.

Library Preparation: The EosBot® Seq Automated Gene Sequencing Library Preparation series integrates magnetic bead purification, PCR amplification, concentration measurement, and normalization functions. Supporting precise pipetting across a wide volume range of 1-1000μL, it enables full automation of both library construction and targeted capture processes. The system is compatible with mainstream domestic and international reagents and sequencing platforms, achieving truly unattended "sample in, library out" operation.

Validated Performance Across Applications

The company has demonstrated the solution's effectiveness through multiple application cases:

Case 1 - Sample Fragmentation Consistency: Using EoSonics® FRAG8 for fragmenting different sample sources showed excellent fragment consistency across rabbit blood DNA samples and FFPE (Formalin-Fixed Paraffin-Embedded) samples.

Case 2 - Library Construction Quality: EoSonics® FRAG8 was used for library construction with 40ng DNA input from human genome samples. Results showed all three samples met library construction quality standards, with Uniformity 0.4X above 89% indicating good coverage uniformity, and On-target rates between 55.5%-64.7% meeting data utilization requirements.

Case 3 - Pathogen Detection: The EosBot® Seq24 library preparation workstation integrated with MGI G99 sequencing platform for pathogen detection. Three different bacterial DNA sequencing results all met quality standards with excellent performance: Q30 consistently stabilized around 90%, with base accuracy fully meeting downstream analysis requirements. Species characteristics and assembly results perfectly matched, with genome length and GC content consistent with corresponding species' biological characteristics, showing no abnormal contamination or identification errors.

Case 4 - Methylation Library: A Beijing tertiary hospital client used EoSonics® FRAG96 for nucleic acid fragmentation and EosBot® Seq24 for methylation library construction. Results showed library concentration and main peak both met downstream sequencing requirements.

Case 5 - NIPT Application: EosBot® Seq24 based on NIPT hybridization capture library preparation kit with 25μL cfDNA input was tested against manual library preparation. Automated process average library concentration was 61.3ng/μL versus manual process at 63.4ng/μL. Pre-library difference was 3%, final library difference was 11%, meeting client requirements. Sequencing results showed high consistency between manual and automated methods.

Case 6 - High-Throughput NIPT: Based on EosBot® Seq96 library preparation workstation for NIPT hybridization capture application, pre-library concentration averaged 93ng/μL, final library concentration 39.7ng/μL. Peak maps showed good consistency, and comparison with competing products demonstrated superior capture efficiency.

Additionally, the EosBot® Seq series has successfully constructed libraries suitable for nanopore sequencing, demonstrating excellent performance in library quality, output stability, and process consistency, surpassing manual operations.

Company Background and Growth

Founded in late 2021, QingYuan KaiWu focuses on the upstream segment of the life science and biopharmaceutical industries. The company has applied for over 90 independent intellectual property rights and has obtained qualifications including "National High-Tech Enterprise," "Beijing Specialized, Refined, Distinctive, and Innovative Small and Medium Enterprise," "Beijing Innovative Small and Medium Enterprise," and "Zhongguancun High-Tech Enterprise." The company has also completed quality management system certification, environmental management system certification, and occupational health and safety management system certification. To date, QingYuan KaiWu has completed four rounds of financing.

In the sequencing sample preparation field, the company has established itself as a manufacturer with full certification for mid-to-high throughput nucleic acid fragmentation clinical applications, and as a comprehensive supplier of fully certified integrated sequencing sample preparation solutions.

The dual certification achievement represents a significant milestone in QingYuan KaiWu's technical R&D capabilities and compliance system development, marking a new starting point for the company's deep engagement in the clinical precision medicine sector. The company plans to continue focusing on innovation and iteration of upstream sequencing equipment and supporting systems, continuously optimizing the integrated sample preparation solution, expanding its product matrix, and enhancing technical performance to provide compliant, efficient, and stable domestic sequencing sample preparation full-chain services for medical institutions and third-party testing laboratories.