Shanghai Ruijing Biotechnology

Shanghai Ruijing Biotechnology Co., Ltd. (Rigen Bio), established in August 2017, is a high-tech enterprise focused on providing molecular diagnostic solutions for precision medicine, with a particular specialization in thyroid cancer. The company was founded by Mr. Hong Gendong, who serves as the legal representative and brings over two decades of experience in commercializing clinical products and team management, including a successful career at Boehringer Ingelheim. His commercial expertise is complemented by a strong R&D team led by CSO Dr. Yang Feng, a Peking University molecular medicine Ph.D., and CTO Dr. Shi Han, a Tsinghua University graduate with a Ph.D. from Northwestern University.

The company operates in the rapidly growing field of in-vitro diagnostics (IVD), specifically targeting the significant clinical need for better diagnosis and management of thyroid nodules and cancer. Its business model integrates the entire process from research and development to manufacturing, sales, and service. Rigen Bio generates revenue by selling its diagnostic products and providing testing services to healthcare institutions. Its client base primarily consists of large, top-tier (Class A Grade 3) general and specialized cancer hospitals across more than fifteen provinces in China.

Rigen Bio has developed a comprehensive product portfolio that covers the entire clinical pathway for thyroid cancer, from initial diagnosis to post-operative monitoring. A cornerstone achievement is the 2023 NMPA approval of its “Human BRAF/TERT/CCDC6-RET Gene Mutation Detection Kit (Fluorescence PCR method),” the first-of-its-kind product approved in China for pre-operatively assessing indeterminate thyroid nodules. The company's offerings also include a specially designed disposable thyroid biopsy needle, various multi-gene qPCR and Next-Generation Sequencing (NGS) testing kits, and the Thyroscan® classifier, which uses machine learning to assess nodule malignancy. These products provide an integrated solution for physicians, aiding in the accurate classification of thyroid nodules, which helps to avoid unnecessary surgeries and reduces the burden on healthcare resources.

Keywords: molecular diagnostics, thyroid cancer, precision medicine, in-vitro diagnostics, gene mutation detection, cancer diagnosis, qPCR, Next-Generation Sequencing, NMPA approved, liquid biopsy, oncology, medical devices, BRAF mutation, TERT mutation, RET fusion, clinical laboratory services, cancer diagnostics China, biotechnology, genetic testing, thyroid nodule classification