RIGEN-BIO Advances a New Paradigm in Thyroid Cancer Management by Addressing Unmet Medical Needs with Top-Tier Clinical Evidence

On June 26, 2021, the First National Academic Conference on Medical Oncology of Thyroid Tumors was held in Tianjin. Experts from multiple disciplines reached a broad consensus: the single-discipline model is gradually becoming obsolete, while the multidisciplinary team (MDT) model integrating surgery, internal medicine, nuclear medicine, and pathology, along with multidisciplinary expert consensus, has propelled the treatment of thyroid tumors into an era characterized by comprehensive multidisciplinary collaboration and precise, refined management. Molecular diagnosis of thyroid tumors, as well as the development and clinical research of targeted therapies emerging thereof, also became major topics of discussion at the conference.

The 1st National Academic Conference on Medical Oncology of Thyroid Tumors

Shanghai Ruijing Biotechnology Co., Ltd. (hereinafter referred to as “Ruijing Bio”) participated extensively in the conference, where it unveiled preliminary results from its collaborative project with Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, on building a single-disease cohort database for the molecular biology of thyroid cancer. During the conference, Ruijing Bio also convened an investigator meeting for the multicenter, prospective, double-blind clinical trial titled “ThyroScan, a Next-Generation Sequencing-Based Diagnostic Test for Thyroid Nodules,” successfully launching the trial.

Selected Representatives from Shanghai Ruijing Biotechnology Co., Ltd.

For a long time, clinical development and medical strategies in the field of in vitro diagnostics (IVD) have lagged behind those in the biopharmaceutical innovation sector. IVD products have been burdened with excessive demands for “scientific research” and “publication,” leading to molecular testing based on single-center retrospective case studies that repetitively generate dispensable “evidence.” This has, to some extent, fueled intense intra-industry competition, diverting focus from unmet medical needs and hindering the creation of genuine medical value. Since its inception, RayGen Biotech has adhered to a dual emphasis on preclinical research and clinical development. Addressing unmet medical needs in the diagnosis and treatment of thyroid nodules and thyroid tumors, the company has designed a rich and well-stratified product pipeline anchored in, but not limited to, molecular diagnostic products. Meanwhile, RayGen Biotech remains committed to shaping its clinical development strategy with top-tier industrialization thinking, leveraging high-quality clinical studies to demonstrate and uncover the medical value of its products.

Professor Dong Lei, Head of Molecular Pathology at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, presented the preliminary achievements in establishing a single-disease cohort for the molecular biology of thyroid cancer, a collaborative effort between RayGene Biotechnology and Ruijin Hospital. In this study, RayGene Biotechnology provided industrial-grade Source Data Verification (SDV), data cleaning, and medical data review to ensure high-quality data entry. Based on this high-quality data, medical coding was performed in accordance with medical dictionaries, followed by visualization and interactive programming. RayGene Biotechnology has pioneered the establishment of a Clinical Data Science department within the industry, integrating multiple modules including report interpretation, data management, statistical programming, and bioinformatics analysis, thereby laying a solid foundation for data management in future prospective clinical trials.

Prof. Dong Lei Reports Preliminary Achievements in the Construction of a Single-Disease Molecular Biology Cohort Database for Thyroid Cancer

During the conference, Ruijing Biology, as the sole in vitro diagnostics (IVD) company, convened an investigator meeting for the “Multicenter, Prospective, and Double-Blind Clinical Trial of ThyroScan, a Next-Generation Sequencing-Based Diagnostic Tool for Thyroid Nodules.” Co-led by Professor Zheng Xiangqian from Tianjin Medical University Cancer Institute and Hospital and Professor Guan Haixia from Guangdong Provincial People’s Hospital, this study involves seven thyroid diagnosis and treatment centers. It aims to evaluate the diagnostic performance of Ruijing Biology’s ThyroScan classifier for differentiating benign from malignant thyroid nodules (primary endpoint) and to conduct a double-blind, head-to-head superiority comparison with conventional cytopathology (secondary endpoint). Notably, the clinical trial is expected to incorporate Ruijing Biology’s first domestically developed thyroid biopsy needle. After 18 months of research and development, this biopsy needle has been submitted for registration testing and is anticipated to be deployed before the Last Patient In (LPI) milestone of the trial. This marks Ruijing Biology’s evolution from a standalone IVD enterprise into a disease-centric platform solution provider.

Ruijing Biotech’s newly developed ThyroScan, a classifier for differentiating benign from malignant thyroid nodules, is a qualitative next-generation sequencing (NGS)-based assay that detects various molecular alterations across 131 genes in fine-needle aspiration (FNA) samples of thyroid nodules. These alterations include gene mutations (SNVs/indels) at over 20,000 hotspots in 62 genes, more than 240 distinct types of gene fusions, copy number alterations (CNAs) in 28 genes, and gene expression alterations (GEAs) in 45 genes. Leveraging machine learning algorithms to assign scores to these molecular events, ThyroScan enables the differentiation of benign versus malignant thyroid nodules and risk stratification of malignant lesions. According to internally validated data released by the researchers, library construction was successful in 98% of FNA specimens. Based on an internal validation cohort of 441 cases, the positive percent agreement was 92.42%, the negative percent agreement was 98.35%, the positive predictive value was 97.86%, and the negative predictive value was 94.09%, positioning ThyroScan as a potential best-in-class diagnostic tool for differentiating benign from malignant thyroid nodules.

The session opened with remarks by Professor Gao Ming, Chair of the Thyroid Cancer Professional Committee under the Oncology Branch of the Chinese Medical Association. Professor Zheng Xiangqian, Lead Investigator and Director of the Department of Thyroid and Neck Tumors at Tianjin Medical University Cancer Institute and Hospital, presented the study protocol and shared preliminary internal testing data from ThyroScan. The participating principal investigators (PIs) then jointly discussed the study protocol and its implementation.

The Medical Monitor for this clinical trial is Dr. Wang Weige, Chief Medical Officer of Ruijing Biopharma, who brings extensive experience in the global clinical development of innovative drugs in China. The Clinical Study Team, independently established by Ruijing Biopharma, comprises professionals in clinical operations project management, clinical research assistance, data management, and regulatory affairs. Against the backdrop of high homogenization in preclinical R&D for in vitro diagnostics, a fully in-house, comprehensively equipped, and autonomously operated clinical development team represents one of Ruijing Biopharma’s distinct advantages. The team will undertake multiple registrational and non-registrational clinical trials, striving to establish clinical development and regulatory affairs as industry-leading capabilities and core competitive strengths.

Address by Professor Gao Ming

Professor Zheng Xiangqian Introduces the Research Protocol

Dr. Wang Weige, Chief Medical Officer of the Sponsor, Participated in Protocol Discussion

Group Photo of On-Site Investigators

As the grand event draws to a close, Ruijing Bio will continue its relentless R&D efforts to provide oncology patients with powerful tools against disease. Leveraging next-generation technologies and research, the company aims to establish itself as a leading provider of both hardware and software solutions for disease combat.

Vision and Mission of Ruijing Biotech