World’s First! GensKey’s mNGS Kit Receives Class III Certification, Marking the Entry of High-Throughput Pathogen Diagnosis into the Era of Standardization

GensKey’s self-developed mNGS kit has officially obtained the Class III medical device registration certificate from the National Medical Products Administration (NMPA). This is not only the first Class III registration certificate in the field of pathogen metagenomic next-generation sequencing (mNGS) testing in China, but also the world’s first mNGS infectious pathogen diagnostic kit approved for market launch by a national-level drug regulatory authority.

Globally, the clinical translation and product registration of mNGS technology represent a common challenge faced by regulatory authorities in various countries.

To date, the U.S. FDA has not approved any mNGS diagnostic kits for market release. The cerebrospinal fluid (CSF) mNGS assay developed by the UCSF team and commercialized by Delve Bio has only received FDA Breakthrough Device Designation; it continues to be offered as a Laboratory Developed Test (LDT) in CLIA-certified laboratories, with patient enrollment for its IMPACT clinical study not commencing until May 2026. Similarly, Karius’ plasma cell-free DNA (cfDNA) test for pulmonary infections in immunocompromised patients has also obtained Breakthrough Device Designation but remains available as an LDT service through CLIA-certified central laboratories, without having secured FDA approval for kit commercialization.

Following the formal implementation of the EU In Vitro Diagnostic Regulation (IVDR), stricter requirements have been imposed on clinical evidence, performance validation, and notified body assessment for IVD products. Currently, no broad-spectrum infectious pathogen mNGS sequencing kits have completed registration approval.

China’s ability to lead the breakthrough stems from robust real-world clinical demand and clear clinical benefits driven by technological iterations. According to Frost & Sullivan data, the domestic market for pathogenic microorganism testing has continued to expand: the volume of such tests in Chinese hospitals grew from 88 million in 2020 to 148 million in 2024, representing a compound annual growth rate (CAGR) of 13.9%; the test volume is projected to reach 331.5 million by 2035. mNGS and tNGS are in a stage of low penetration but high growth, with the combined testing volume for these two technologies rising from 300,000 in 2020 to 3.1 million in 2024, at a CAGR of 79.3%.

Urgent clinical demands are driving technology toward standardization and facilitating the implementation of product approval and reimbursement policies. While the United States remains in the exploratory phase of Laboratory Developed Tests (LDTs) and the European Union is in a regulatory transition period, China has already completed the rigorous full-process review for Class III medical devices. This has achieved a regulatory leap for metagenomic next-generation sequencing (mNGS) in the pathogen diagnosis of bloodstream infections, transitioning from LDT services to standardized In Vitro Diagnostic (IVD) products. With the market launch of Class III test kits and the establishment of reimbursement items, the industry is poised to unlock a billions-yuan incremental market space.

The global disease burden caused by infectious diseases is comparable to that of cardiovascular diseases and cancer. Leveraging advantages such as the absence of predefined targets, broad pathogen coverage, and the ability to detect unknown pathogens, metagenomic next-generation sequencing (mNGS) has become a core diagnostic tool for severe infections, complex and difficult-to-diagnose infections, and infections in immunocompromised populations.

However, prior to this, global mNGS pathogen testing was predominantly conducted through central laboratory services. The lack of unified standards for reagent formulations, experimental protocols, sequencing depth, and bioinformatics analysis rules across different medical institutions resulted in insufficient comparability of test results, severely limiting the widespread clinical adoption of this technology.

The approval of this Class III medical device certification fundamentally changes the current landscape. The kit has passed registration testing, multicenter clinical trials, and on-site clinical trial inspections across all aspects—from reagent components and experimental procedures to data quality control and bioinformatics analysis. This ensures stable and comparable test results across different institutions and batches, thereby removing the core barriers to the widespread adoption of mNGS kits in hospitals.

In December 2021, the National Development and Reform Commission (NDRC) released the "14th Five-Year Plan for Bioeconomy Development," listing high-throughput gene sequencing as a key focus of frontier biotechnological innovation.

Clinical experts have successively released expert consensus on the clinical application of mNGS, clarifying its clinical value and usage recommendations in difficult-to-diagnose and severe infections.

On December 31, 2025, the national standard GB/T 46943‑2025, titled “General Requirements for Performance Verification of Pathogen Metagenomic High-Throughput Sequencing in Clinical Laboratory Testing and In Vitro Diagnostic Systems,” was officially released and will come into effect on January 1, 2027, filling the gap in China’s national standards for performance evaluation of mNGS laboratories. In April 2026, the “Guidelines for Standardized Clinical Application of Metagenomic High-Throughput Sequencing Technology in Clinical Laboratories (2026 Edition)” was published in the Chinese Medical Journal, providing 15 recommendations covering laboratory environment, personnel, specimens, wet and dry laboratory workflows, quality control, and report interpretation, to guide hospitals at all levels in conducting mNGS testing in a standardized manner.

On August 14, 2026, the National Healthcare Security Administration issued the “Guidelines for Establishing Pricing Items for Laboratory Medical Services (Trial),” establishing nationally uniform, separately billable items for mNGS and tNGS pathogen testing: mNGS is billed per test, regardless of the number of pathogens detected; tNGS is priced by test panel.

In the absence of global precedents for mNGS registration, the National Medical Products Administration (NMPA) maintained ongoing communication with enterprises and convened multiple expert panels to address key challenges one by one, including the scope of pathogen validation, positive cutoff values, comparative methods, laboratory management, and reporting scope. After eight years of effort, GensKey completed two clinical trials (involving a cumulative total of approximately 4,000 samples) and passed on-site clinical trial inspections, ultimately securing the first-ever approval certificate.

From clinical application scenarios to standardized laboratory operations, and further to the implementation of billing items and the approval of the first Class III medical device certificate, the full-chain compliance pathway for clinical metagenomic testing in China has been fully established, marking a transition from the limited Laboratory Developed Tests (LDT) model to a quality-standardized in vitro diagnostics (IVD) model.

Obtaining the registration certificate for the mNGS kit for bloodstream infections is merely the beginning of GensKey’s product portfolio strategy. The company will next expand into indications for additional sample types, such as respiratory specimens, while simultaneously advancing the regulatory submissions for targeted sequencing kits and AI-assisted diagnostic software, thereby building a comprehensive portfolio of pathogen diagnostics products that covers diverse clinical scenarios and sample types.

Looking at the development of the industry, the large-scale explosion of niche tracks always begins with the standardization and commercialization of key technologies. The emergence of China’s first Class III medical device certification for mNGS-based infectious pathogen diagnosis not only validates the innovative capabilities of domestic enterprises but also marks China’s leadership in establishing regulatory frameworks for the mNGS pathogen diagnostics sector, officially ushering the industry into a new era of standardization.