 Recently, Simcere Diagnostics, a provider of precision medicine solutions, announced a collaboration with Illumina, the global leader in gene sequencing and microarray technology, in the field of oncology precision medicine.This collaboration is dedicated to expanding the clinical application of next-generation sequencing (NGS) technology in oncology testing, thereby further promoting the standardized development of precision diagnosis and treatment for malignant tumors in China.Simcere Diagnostics will develop novel cancer genetic diagnostic products tailored to the needs of Chinese patients, based on Illumina’s TruSight™ Oncology 500 (TSO 500) pan-cancer genomic testing kit.
Illumina TSO 500 is a pan-cancer, large-panel product based on next-generation sequencing (NGS) technology that enables comprehensive analysis of all variant types across 523 tumor-associated genes, including single-nucleotide variants, insertions and deletions, copy number variations, and gene fusions. Furthermore, TSO 500 can accurately detect key biomarkers associated with the efficacy of mainstream immunotherapies, including microsatellite instability (MSI) and tumor mutational burden (TMB).
TruSight™ Oncology 500, Source: Illumina Official Website In early 2019, Illumina’s novel pan-cancer large-panel product, developed based on the TSO 500, was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) to facilitate FDA approval through an expedited “green channel” process.The product jointly developed by both parties will be based on TSO 500 technology, creating an oncology genetic testing product that better meets the needs of the local Chinese market.“Simcere Diagnostics has been committed to creating a precise, comprehensive, rapid, and accessible diagnostic product and service system in areas of major challenges to human health.”Appointment of the Chairman and Chief Executive Officer of Simcere Diagnosticsstated, “CurrentlyNational Medical Products Administration (NMPA) of China“Only companion diagnostic products targeting specific cancer types and known hotspot mutations have been approved. This collaboration is expected to accelerate the introduction of the first NMPA-approved pan-cancer large-panel tests in China, thereby further promoting the standardized development of precision diagnosis and treatment for malignant tumors in China and benefiting more cancer patients.”According to statistics from the World Health Organization (WHO), there were approximately 4.3 million new cancer cases in China in 2018, and about one in five Chinese people will develop cancer before the age of 75.[1]。Li Qing, Global Vice President and General Manager of Greater China at Illumina, stated, “Malignant tumors pose a significant threat to the health and well-being of residents in China. With the rapid advancement of precision oncology, clinicians and patients alike have raised higher expectations for comprehensive, reliable, and accessible high-quality genetic testing.”Simcer Diagnostics, a subsidiary of Simcere Holdings under Sinopharm Group, is a leading provider of precision medicine solutions in China, with proven market access expertise and an in-depth market presence. We are delighted to partner with Simcer Diagnostics to jointly advance the commercialization of globally leading oncology genetic testing products in the Chinese market.”[1] the IARC Global Cancer Observatory (2018). Population Fact Sheets-China. Retrieved from https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdfAbout Simcere DiagnosticsSimcere Diagnostics is a provider of precision medicine solutions under Simcere Holdings, a subsidiary of China National Pharmaceutical Group. The company is dedicated to creating a diagnostic product and service ecosystem that is precise, comprehensive, rapid, and accessible, addressing major challenges in human health. By integrating multiple leading molecular testing platforms with bioinformatics analysis capabilities, Simcere Diagnostics provides the foundation for precision medicine decision-making for healthcare professionals and medical institutions in therapeutic areas such as oncology, central nervous system disorders, infections, pharmacogenomics, and autoimmune diseases. Additionally, Simcere Diagnostics offers direct-to-consumer medical testing services, enhancing the quality, efficiency, and experience of public healthcare through innovative service models.Simcere Diagnostics Official Website:http://www.simceredx.com/Illumina, Inc. is dedicated to advancing and inspiring the development of genomics to continuously improve human health. Our focus on innovation has made us a global leader in gene sequencing and array technology, providing professional services to customers in research, clinical, and applied markets worldwide. Our products are widely used in life sciences, oncology, reproductive health, agriculture, and other emerging fields. For more information, please visit www.illumina.com or follow Illumina’s official WeChat account. | 
