Genetron Health Receives CE Mark for 8 Genes Lung Cancer

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BEIJING, July 13, 2021 (GLOBE NEWSWIRE) — Genetron Holdings Limited (“Genetron Health” or the “Company”, NASDAQ:GTH), a leading precision oncology platform company in China specializing in molecular profiling assays, early cancer screening products and the development of companion diagnostics, today announced that it has received the CE mark for its 8-gene lung cancer test. Separately, the company also reported comparative data demonstrating the sensitivity performance of the Genetron SARS-CoV-2 RNA test.

The CE mark represents the second regulatory milestone for the 8-gene lung cancer test as it has already been approved by China’s NMPA and is being marketed in China. Based on the company’s proprietary One-Step Seq method, this product provides fast and easy-to-use testing procedures suitable for independent use in hospitals. With the One-Step Seq technology, the library building process is completed in one reaction step, minimizing manual handling to one mixture of reagents with DNA/cDNA. The chance of contamination in the process is minimal with the workflow “sample in library out”. The assay is compatible with the Genetron S5 sequencing platform and together they provide a two day turnaround time from sample to report. The 8-gene Lung Cancer Assay includes mutations of EGFR, BRAF, KRAS, HER2, and PIK3CA, translocations of ALK and ROS1, and MET exon 14 skipping, and 7 of these genes are recommended biomarkers by the 2018 NCCN guideline for non-small cell Lung cancer (NSCLC) patients. Several targeted therapy drugs such as Gefitinib, Osimertinib, Crizotinib, and Savolitinib have been approved by the NMPA for treatments of NSCLC patients with those genomic changes.
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“We are delighted to receive the CE mark, which represents an important new commercialization opportunity for our 8-gene lung cancer test. Together with our Genetron S5 and fully automated bioinformatics solutions, we provide an end-to-end, fast turnaround and seamless workflow for hospitals and clinical labs that prefer to perform NGS testing in-house. We believe this provides a significant operational advantage for our customers outside of China and we have received very positive feedback since its launch in China,” said Sizhen Wang, co-founder and CEO of Genetron Health.

Separately, the company also reported comparative performance data from its SARS-CoV-2 RNA test based on a SARS-CoV-2 reference panel established by the US Food and Drug Administration (FDA). The purpose of the reference panel is to enable a more accurate comparison of the analytical performance of various in vitro molecular diagnostic (IVD) assays intended to detect SARS-CoV-2. Results of this panel’s blinded tests showed that the sensitivity or limit of detection (LoD) of Genetron’s SARS-CoV-2 RNA test was 1,800 NDU/ml, which was the best of all domestic companies in China in the same category, and did it also compares well with international companies. Background information and peer data on this FDA reference panel initiative can be found at the: FDA website.

In June 2020, Genetron Health received Emergency Use Authorization (EUA) from the FDA for the independently developed SARS-CoV-2 RNA test for the novel coronavirus. In addition, the kit received approval for export from the relevant authorities in China (Press release).

Mr. Wang continued: “Since the beginning of the pandemic, we have provided this test to various risk areas around the world. This FDA initiative allows us to fairly compare our product with other manufacturers, and we are pleased to have achieved the best performance among the domestic companies, further demonstrating our company’s ability and commitment to the delivering high-quality molecular diagnostic solutions.”

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 uses advanced technologies in molecular biology and data science to transform cancer treatment. The company has developed a comprehensive oncology portfolio spanning the entire spectrum of cancer management, addressing the needs and challenges of early screening, diagnosis and treatment recommendations, as well as continuous disease monitoring and care. Genetron Health also partners with global biopharmaceutical companies to provide customized services and products. For more information, visit ir.genetronhealth.com.

Safe Harbor Statement
This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about research results and genomic research, Company’s One-Step Seq Method, optimization studies of clinical routine diagnosis methods 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 in any forward-looking statement. In some instances, forward-looking statements can be identified by words or expressions such as “may”, “will”, “expect”, “anticipate”, “aim”, “aim”, “estimate”, “intend”, “plan”, “believe”, “potential”, “continue”, “is/will likely” or other similar expressions. More information about these and other risks, uncertainties or factors is contained in the company’s filings with the SEC. All information in this press release is as of the date of this press release, and the company assumes no obligation to update such information, except as required under applicable law.

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David Deuchler, CFA
Director | Gilmartin Group
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Media Relations Contact
Yanrong Zhao
Genetron Health
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Edmond Lococo
ICR
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Genetron Health Receives CE Mark for 8 Genes Lung Cancer

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