BEIJING, June 01, 2022 (GLOBE NEWSWIRE) — Genetron Holdings Limited (“Genetron Health” or the “Company”, GTH), a leading precision oncology platform company in China that specializes in providing molecular profiling, early cancer screening products and development of companion diagnostics, announced today that it has obtained CE Mark for its FusionScan Plus kit, an integrated test based on DNA and RNA NGS to simultaneously detect multiple mutations and gene fusions with lower thresholds, (registration number: DE/CA20/01-IVD -Luxuslebenswelt-886/22).
Obtaining CE Mark is an important step in accelerating the global footprint of FusionScan Plus and its potential to enter other international clinical trials in the future.
Based on Genetron Health’s One-Step™ Seq method, FusionScan Plus covers 29 tumor-related mutant genes and 40 fusion genes. FusionScan Plus overcomes the limitations of traditional detection methods. With lower threshold requirements and a faster process, it can simultaneously detect drug-susceptible or drug-resistant gene mutations at the DNA level, and fusions of known and unknown partner genes at the RNA level, in tumor tissue samples. It can provide an effective reference for clinical pathology classification, formulation of targeted treatment strategies, and development of new drugs.
Genetron Health announced the results of the FusionScan Plus study at the 2021 Annual Meeting of the Association for Molecular Pathology. Detection results from 76 formalin-fixed, paraffin-embedded (FFPE) clinical specimens have proven that FusionScan Plus exhibits high accuracy in detecting mutations and gene fusions without a priori knowledge of the 5′ fusion partner. It can accurately detect drug sites for cancer patients and screen the population for targeted therapies, even with limited biopsy specimens, thereby improving clinical benefits for patients.
Genetron Health has actively promoted the clinical validation and commercial distribution of several IVD products in domestic and overseas markets. Currently, human IDH1 gene mutation detection kit (PCR-fluorescent probe method), human TERT gene promoter mutation detection kit (PCR-fluorescent probe method), human gene 8 mutation joint (semiconductor sequencing method), human gene 825 mutation detection Kit (probe-anchored polymerization sequencing combination method), Human B Lymphocyte Minimal Residual Disease Detection Kit (method reversible-termination sequencing) and other products have successively obtained the EU CE mark. In the future, the Company will closely follow the clinical needs of molecular detection, accelerate the commercialization of products and provide patients with more accurate and accessible medical services.
About CE Marking
CE marking stands for EUROPEAN CONFORMITY, a certified safety mark, and is considered a passport allowing manufacturers to open up and enter the European market. In the EU market, the CE mark is a mandatory certification mark, whether it is a product produced within the EU company or a product produced in other countries. . In order to circulate freely in the EU market, a CE mark must be added to indicate that the product meets basic EU requirements. For more information:
About Genetron Investments Limited
Genetron Holdings Limited (“Genetron Health” or the “Company”) (GTH) is a leading precision oncology platform company in China that specializes in molecular cancer profiling and leverages advanced technologies in molecular biology and in data science to transform cancer treatment. The company has developed a comprehensive oncology portfolio that spans the full spectrum of cancer management, addressing the needs and challenges of early detection, diagnosis and treatment recommendations, as well as monitoring and care. continuations of the disease. Genetron Health also partners with global biopharmaceutical companies and offers customized services and products. For more information, please visit ir.genetronhealth.com.
Safe Harbor Statement
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