Since Genetron Holdings Limited (hereinafter referred to as "Genetron") signed a cooperation agreement with AstraZeneca Global R&D China Center (hereinafter referred to as "AstraZeneca") in November 2021, after two years of product validation, the two parties recently officially launched an exclusively co-developed solid tumor personalized custom Minimal Residual Disease (hereinafter referred to as “MRD”) detection product based on Next-Generation Sequencing (NGS) technology. This product has become the first solid tumor MRD product in China jointly developed by a precision medicine company and a globally renowned pharmaceutical enterprise, having undergone comprehensive performance verification. After being thoroughly evaluated by AstraZeneca, the product will be applied in AstraZeneca’s drug development and exploratory clinical research, among other areas.
According to Sullivan Research data, the MRD market size in China was 1.2 billion yuan in 2023 and is expected to rapidly grow to 18.5 billion yuan by 2030. To accelerate the development of diagnostic technologies in China and better meet the needs of cancer patients, Genetron Holdings Limited will collaborate with a wide range of pharmaceutical companies, including AstraZeneca, to advance the IVD registration and full commercialization of this product. Additionally, Genetron will also expand its broader cooperation with more large pharmaceutical enterprises based on this product.
Genetron Holdings Limited's MRD Product for Solid Tumors Adopts Tumor-informed Technology Strategy. It Establishes a Gene Mutation Profile Based on Whole Exome Sequencing (WES) of Tissue and Utilizes Genetron’s Patented "Mutation Capsule (ZL 201910983038.8)" to Customize an Exclusive MRD Panel for Patients with Various Solid Tumors. It Can Be Used for Stage I-III Lung Cancer, Colorectal Cancer, Liver Cancer, Gastric Cancer, Pancreatic Cancer, Esophageal Cancer, and Other Solid Tumor Populations, Tracking Gene Variations Related to Tumor Recurrence, Prognostic Evaluation, and Adjuvant Therapy, Supporting Treatment and Prognostic Management of Early and Locally Advanced Solid Tumors.
Its detection performance has been established and confirmed through large-scale standards and clinical samples: with an average sequencing depth of 80,000X-100,000X, the Limit of Detection (LOD) of the ctDNA customized Panel reaches 0.01% with a detection rate ≥95%, surpassing the standard in the "2021 Expert Consensus on Molecular Residual Disease in Non-Small Cell Lung Cancer," which requires MRD detection abundance to be ≥0.02% ctDNA.
Moreover, during the clinical performance verification phase, this product conducted whole-exome sequencing and customized MRD panels for hundreds of global clinical tumor samples from AstraZeneca. These samples included nearly 30 types of solid tumors such as lung cancer, colorectal cancer, liver cancer, gastric cancer, cervical cancer, pancreatic cancer, breast cancer, prostate cancer, bladder cancer, and rhabdomyosarcoma. Subsequently, peripheral blood was collected at different time points to track mutations and calculate MRD, with LOD reaching 0.01%.
Dr. He Jing, Senior Vice President of AstraZeneca Global and Head of AstraZeneca Global R&D China Center, stated: "The development of the solid tumor MRD test in collaboration with Genetron Holdings Limited is another successful case of a strong partnership between a multinational pharmaceutical company and a Chinese diagnostic company. This high-quality test will help patients achieve precision treatment, benefiting more cancer patients in and outside of China."
Genetron Holdings Limited Co-founder, Chairman and CEO Sizhen Wang said: "The successful launch of the product in collaboration with AstraZeneca lays a solid foundation for more drug clinical research and marketing cooperation in the future. Relying on Genetron’s proprietary Mutation Capsule technology, the sensitivity of MRD products has been significantly improved, enhancing patient screening efficiency. In collaborating with a well-known multinational pharmaceutical company like AstraZeneca, their contribution of hundreds of high-quality gold-standard clinical samples allowed the product to undergo full clinical validation, demonstrating robust and reliable performance. In the future, we will continue to focus on developing more innovative diagnostic products and solutions for cancer patients."
Genetron Holdings Limited (NASDAQ: GTH) is a global leading precision oncology company, focusing on cancer genomics research and applications. It provides products and services covering the entire cancer care continuum, including early cancer screening, treatment guidance, prognosis and monitoring, as well as new drug development services for tumors. The company is committed to applying innovative genomic technologies to cancer-related diagnosis and treatment, with the ultimate goal of conquering cancer.
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(Translational Medicine Network 360zhyx.com)
