On June 23, 2026, Shanghai RuiJing Biotechnology Co., Ltd. (hereinafter referred to as "RuiJing Bio") independently developed the "Human BRAF/TERT/RET/NTRK3 Gene Mutation Detection Kit (Joint Probe Anchoring Polymerization Sequencing Method)" officially received a Class III Medical Device Registration Certificate (Registration No.: 20263401321) issued by the National Medical Products Administration (NMPA). As the first and only NGS-based thyroid cancer molecular detection kit approved in China, this certification fills a critical gap in compliant clinical NGS applications, offering clinicians a more diversified and comprehensive precision diagnostic solution, and marking the official entry of thyroid cancer molecular diagnostics into the NGS era.
In recent years, thyroid cancer has become the fastest-growing malignancy globally and in China. According to the latest domestic epidemiological data, the number of new thyroid cancer cases now ranks second among all malignant tumors, second only to lung cancer. Precision diagnosis and treatment of thyroid cancer rely on a comprehensive understanding of core driver genes and additional mutations acquired during disease progression, with the overall molecular variation pattern exhibiting a distinct "long-tail" distribution.
With the deepening of the precision oncology era, the clinical value of NGS technology in companion diagnostics and personalized treatment has been widely recognized. Compared with traditional PCR methods—which are limited by single-site detection and insufficient sensitivity—NGS can simultaneously and comprehensively detect multiple variant types, including point mutations, insertions/deletions, and gene fusions, providing a one-stop "panoramic" molecular testing solution for clinical practice.
Internationally, NGS-based molecular diagnostic products for thyroid cancer have been widely adopted in clinical practice. RuiJing Bio has closely aligned with China's actual clinical needs and established a compliant in-hospital solution based on a dual PCR+NGS platform. This not only provides a more precise molecular subtyping tool for differentiating benign from malignant nodules but also delivers more comprehensive molecular evidence for recurrence risk stratification, surgical/ablation treatment decisions, RAI therapy efficacy prediction, targeted therapy guidance, and scientific research. This represents a true leap from "rough screening" to "precise guidance."
Efung Capital participated in RuiJing Bio's financing in 2025. Looking ahead, Efung Capital will continue to monitor developments in the thyroid precision diagnostics sector, steadfastly supporting RuiJing Bio's continued deep cultivation of NGS-based molecular diagnostics and expansion of its product pipeline.
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