Genetron Health’s Multi-Gene Mutation Detection Kit Onco PanScan™ Obtains CE Mark
Genetron Holdings Limited (Nasdaq: GTH) announced that its Onco PanScan™ product received the CE mark, allowing for marketing in the European Union. This genomic profiling test covers over 800 genes, aiding personalized cancer treatment and targeted therapy. The CE mark signifies compliance with EU standards, crucial for market access. Genetron also holds approvals for other assays in China and is preparing for an IVD registrational trial. CEO Sizhen Wang emphasized the company’s growth across various business lines in molecular diagnostics.
- Onco PanScan™ received the CE mark, enabling entry into the EU market.
- Test covers over 800 genes, aligning with international treatment guidelines.
- Genetron has multiple approved products in China, enhancing its portfolio.
- None.
BEIJING, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Genetron Holdings Limited (“Genetron Health” or the “Company”) (Nasdaq: GTH), a leading precision oncology company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, today announced that its proprietary large-panel product, Onco PanScan™ (Mutation Detection Kit for Human Multi-Genes), has obtained the CE mark, a compulsory certification mark required for marketing and distribution in the European Union.
Onco PanScan™ is Genetron’s comprehensive genomic profiling test, and is based on hybridization capture and next-generation sequencing (NGS) technology. By combining coverage of different gene mutation regions and genetic variants observed in thousands of cases from different tumor types, the detection kit covers more than 800 genes that are recommended by international treatment guidelines, including World Health Organization (WHO), National Comprehensive Cancer Network (NCCN), and the European Society for Medical Oncology (ESMO). Onco PanScan™ provides comprehensive and accurate genomic profiling to guide personalized medicine for cancer patients with a single test, making it suitable for targeted therapy, immunotherapy (TMB assessments, MSI, immune efficacy-related genes) treatment guidance, and screening for susceptibility to genetic risks.
Aside from Onco PanScan™, the Company’s TERT and IDH1 assays along with 8-Gene Lung Cancer Assay have all been approved in China and have received the CE Marks.
“We are excited to receive another CE Mark this year, in addition to the one that we obtained just a few months ago for our 8-Gene Lung Cancer Assay. In China, Onco PanScan™ is a key LDT product for us, and we are preparing to start our IVD registrational trial shortly. Genetron continues to grow all our business lines spanning early screening to diagnosis and monitoring. We remain committed to providing high-quality, innovative molecular diagnostic testing products to patients around the world,” said Sizhen Wang, Co-founder and CEO of Genetron Health.
About CE Mark
The CE mark stands for CONFORMITE EUROPEENNE, a security-certified mark, and is seen as a passport for manufacturers to open and enter the European market.
In the EU market, the CE mark is a compulsory certification mark, whether it is a product produced within the EU enterprise 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 the basic requirements of the EU. For more information:
https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm
About Genetron Holdings Limited
Genetron Holdings Limited (“Genetron Health” or the “Company”) (Nasdaq: GTH) is a leading precision oncology platform company in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The Company has developed a comprehensive oncology portfolio that covers the entire spectrum of cancer management, addressing needs and challenges from early screening, diagnosis and treatment recommendations, as well as continuous disease monitoring and care. 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
This press release contains forward-looking statements within the meaning of federal securities laws, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as “may”, “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.
Contacts:
Investor Relations
Hoki Luk
Email: hoki.luk@genetronhealth.com
Phone: +1 (408) 891-9255
Media Relations
Yanrong Zhao
yanrong.zhao@genetronhealth.com
FAQ
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