Benzinga | Nov 4, 2021 06:47AM EDT

Genetron Health's Multi-Gene Mutation Detection Kit Onco PanScan Obtains CE Mark

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(tm) (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(tm) 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(tm) 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(tm), 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(tm) 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.