IVD China last week: Roche Diagnostics, Thermo Fisher Scientific and Lead Health, KingMed Diagnostics, Mirxes and N Health, Burning Rock Dx

Roche Diagnostics’ MTB Nucleic Acid Test Kit and Domestic cobas 5800 Molecular Diagnostic System Receive NMPA Approval

Roche Diagnostics China announced that the cobas® MTB Mycobacterium tuberculosis complex nucleic acid test kit (PCR-fluorescence method) has been officially approved by the National Medical Products Administration (NMPA) of China. The assay adopts an innovative dual-target design targeting both the 16S rRNA gene and the multi-copy esx gene, ensuring comprehensive coverage of the Mycobacterium tuberculosis complex (MTBC) while significantly enhancing detection sensitivity compared with traditional single-target assays.

In addition, the cobas® 5800 fully automated nucleic acid extraction and real-time PCR system has also received Class III medical device registration approval from the NMPA. As a domestically manufactured breakthrough product, the cobas® 5800 features a compact footprint of approximately one square meter and a fully automated “sample-in, result-out” workflow. The system supports up to 5.5 hours of unattended operation, delivers first results within 2.5 hours, and can produce up to 144 test results within 8 hours, while simultaneously running up to six different assays. The platform is designed to meet the needs of laboratories of varying sizes, achieving an optimal balance of quality, efficiency, and cost management.

Lead Health and Thermo Fisher Scientific Form Strategic Partnership to Advance Synergistic Development in Life Sciences

Lead Health and Thermo Fisher Scientific have officially signed a strategic cooperation agreement at Guangzhou International Bio Island. The two parties announced that they will collaborate extensively on instruments and solutions for the life sciences and biopharmaceutical sectors, combining Lead Health’s strengths in intelligent equipment with Thermo Fisher’s comprehensive scientific services portfolio.

Thermo Fisher Scientific’s Life Sciences business in China stated: “China’s life sciences industry is entering a golden period of high-quality development. As a representative of local innovative enterprises, Lead Health has demonstrated strong capabilities and significant potential in life sciences technology R&D. This strategic partnership will further deepen our localization strategy, support the global expansion of Chinese innovations, and accelerate the delivery of innovative therapies to patients worldwide.”

KingMed Diagnostics, The Third Affiliated Hospital of Sun Yat-sen University, and Unicom Digital Healthcare Jointly Launch an AI Doctor

The Third Affiliated Hospital of Sun Yat-sen University, KingMed Diagnostics and Unicom Digital Healthcare have jointly announced the official launch of an artificial intelligence doctor. The system is developed based on real-world inpatient cases and complete clinical diagnosis and treatment pathways, enabling advanced clinical reasoning.

The AI doctor is expected to assist clinicians in improving diagnostic and treatment efficiency, while also facilitating the dissemination of high-quality medical expertise and resources to primary healthcare institutions.

The supporting laboratory will focus on the accumulation, governance, and activation of multi-source clinical and health data to establish a high-quality data resource system. Leveraging high-performance computing and intelligent analytics platforms, the laboratory will conduct data modeling, simulation, and algorithm training, forming a closed-loop process from data accumulation to knowledge discovery, thereby reshaping the paradigm and efficiency of medical research.

Mirxes and N Health to Build a New Ecosystem for Early Cancer Screening in Thailand

Mirxes Holding Company Limited recently announced two major milestones in the Thai market. The company has entered into a strategic partnership with N Health, a member of Bangkok Dusit Medical Services (BDMS) Group, and has successfully launched two innovative at-home cancer risk screening kits. These developments mark a significant step forward in Mirxes’ expansion across Southeast Asia.

On January 9, 2026, Mirxes officially launched two at-home cancer risk screening products in Thailand: HELICORapid and FITRapid. The two products received approval from the Thailand Food and Drug Administration in October and December 2025, respectively. HELICORapid is designed for the detection of Helicobacter pylori (H. pylori) infection, a major risk factor for gastric cancer. FITRapid is intended for fecal occult blood testing, an important indicator associated with colorectal cancer or precancerous polyps.

Burning Rock Dx Secures U.S. Patent Authorization for Liquid Biopsy Technology

Burning Rock Dx announced that its proprietary ultra-sensitive detection technology, ELSA-seq, has received authorization from the United States Patent and Trademark Office (USPTO) under patent number US12460202B2. This marks the first U.S. patent granted to the ELSA-seq technology, following prior patent approvals in China.

This milestone represents international recognition of the originality and innovation of Burning Rock Dx’s liquid biopsy technology and signifies a new phase in the company’s compliance-driven and global development strategy. As the core underlying technology powering the company’s flagship products, OverC and CanCatch Surf, ELSA-seq will continue to enable highly sensitive, stable, and reliable liquid biopsy solutions for both research and clinical applications. The technology is expected to drive the transition of liquid biopsy from laboratory research to broader clinical adoption, delivering higher-quality precision diagnostic services to cancer patients worldwide.