Publication in clinical and translational medicine

BEIJING, April 07, 2022 (GLOBE NEWSWIRE) — Genetron Holdings Limited (“Genetron Health” or the “Company”, NASDAQ: GTH), a leading precision oncology platform company in China that specializes in providing molecular profiling assays, cancer early detection product development and companion diagnostics, today announced that a research paper titled “Integrated Analysis of Circulating Tumor Cells and Circulating Tumor DNA to Detect Residual Disease in hepatocellular carcinoma” was published in a highly impactful journal, Clinical and translational medicine (Impact factor: 11.5). The company’s Mutation Capsule™ technology was used in the publication and the full article is available here.

Recurrence is the main cause of mortality after hepatectomy or liver transplantation for HCC.1-4 It is difficult to precisely manage the adjuvant treatment to prevent recurrences after surgery. Using the Mutation Capsule™ technology’s multiplex profiling feature, comprehensive cell-free DNA (cfDNA) analysis was performed, allowing direct comparison of biomarkers and approaches to predict recurrence, including tumor cell profiling (CTC) and circulating tumor DNA (ctDNA) in the same blood samples. In the publication, 66 patients were eligible for analysis using postoperative serial blood samples, and ctDNA status was determined by three strategies:

  • Customized test targeting whole exome sequencing (WES) mutations in tumor samples
  • Universal Panel Targeted Sequencing (UPTS) covering the most common HCC alterations, as well as HBV integration
  • Tumor naïve fixed panel by profiling ctDNA regardless of mutation status in tumor tissues

Predicting recurrence-free survival rates using Kaplan-Meier analysis, UPTS showed strong performance (p

“MRD testing can aid in the clinical management of patients, long before metastatic lesions reach a significant size detectable by conventional methods such as MRI and CT scans. This publication adds to a growing body of evidence clinical trials of Mutation Capsule™, highlighting its versatility in developing MRD tests,” said Sizhen Wang, President, Co-Founder and CEO of Genetron Health. “Test optimization is currently underway with a commercial launch planned for this year. Genetron is also evaluating different biomarkers for the tumor naïve MRD approach. We are excited that these programs can not only expand our product offerings across the continuum of cancer care, but may also help more patients detect recurrent cancer sooner than and current methods.

Recently released MRD test data based on Genetron Health’s Mutation Capsule™ also includes:

  • Data on gastric cancer in the Journal of Hematology and Oncology: The custom MRD assay showed excellent sensitivity in detecting 0.001% tumor DNA from peritoneal lavage fluid samples for accurate prediction of peritoneal dissemination.
  • Data on locally advanced rectal cancer in eBioMedicinepart of THE LANCET Scientific Discovery: Analysis on different MRD approaches after neoadjuvant therapy.

The references
1. Sung H, Ferlay J, Siegel RL, et al. World Cancer Statistics 2020: GLOBOCAN estimates of worldwide incidence and mortality for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-249.
2. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultra-deep sequencing in patients with stage I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124-113.
3. Cai Z, Chen G, Zeng Y. Comprehensive liquid profiling of circulating tumor DNA and protein biomarkers in long-term follow-up patients with hepatocellular carcinoma. Clin Cancer Res. 2019;25(17):5284-5294.
4. Cristofanilli M, Budd GT, Ellis MJ, et al. Circulating tumor cells, disease progression and survival in metastatic breast cancer. NOT English J Med. 2004;351(8):781-791.

About Clinical and Translational Medicine
Clinical and translational medicine is an international peer-reviewed, open-access journal that aims to promote and accelerate the translation of preclinical research into clinical application and communication between basic and clinical scientists. The journal emphasizes the clinical potential and application of new biotechnologies, biomaterials, bioengineering, disease-specific biomarkers, cellular and molecular medicine, omics, bioinformatics, immunology, molecular imaging, drug discovery and development, and health regulation and policy. The journal focuses on the bench-to-bedside approach, emphasizing studies and clinical observations that generate hypotheses and questions relevant to the patient and the disease, and guide investigations of cellular and molecular medicine. For more information, please visit: https://onlinelibrary.wiley.com/page/journal/20011326/homepage/productinformation.html

About Genetron’s MRD Program in Solid Tumors and Mutation Capsule™ Technology

Genetron’s MRD program in solid tumors is based on its Mutation Capsule™ technology. This proprietary technology allows the detection of methylation alterations and mutations in a single reaction, and therefore requires less blood while achieving high detection sensitivity. Additionally, genetic and epigenetic information from the cell-free DNA (cfDNA) sample can be preserved and amplified in the Mutation Capsule™ library, and can be used for multiple analyzes without sacrificing sensitivity. In MRD development, this feature reduces panel validation time and provides direct comparisons between different MRD strategies, saving significant time and money. Mutation Capsule™ also enables more sensitive detection in low yield cfDNA samples, with higher conversion efficiency of cfDNA molecules. The technology was recently granted an invention patent (201910983038.8) by China’s National Intellectual Property Administration.

Co-development agreement with AstraZeneca R&D China for customized MRD tests for solid tumors in China

In November 2021, Genetron announced a collaboration agreement with AstraZeneca R&D China for the joint development in China of next-generation sequencing (NGS)-based, tumor-informed (customized) minimal residual disease (MRD) assays for various types of solid tumors. Under the agreement, the companies will jointly invest capital for this collaboration. For solid tumor clinical trials in China that incorporate the use of NGS-based custom MRD tests, AstraZeneca plans to incorporate the co-developed MRD test into China-specific studies, subject to meeting the criteria for individual study. Following the subsequent agreement of the two companies, the scope of the agreement may also be extended to include the registration and commercialization of IVDs. This is an exclusive, multi-year collaboration agreement between the two parties, with exclusivity subject to certain requirements.

About Genetron Investments Limited

Genetron Holdings Limited (“Genetron Health” or the “Company”) (NASDAQ: GTH) is a leading precision oncology platform company in China that specializes in molecular cancer profiling and leverages advanced technologies in biology molecular and 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

This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. technology 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 instances, forward-looking statements may be identified by words or phrases such as “may”, “will”, “expect”, “anticipate”, “target”, “aim”, “estimate”, ” intends to”, “plans”, “believes”, “potential”, “continues”, “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 speaks as of the date of this press release, and the Company undertakes no obligation to update such information except as required by applicable law.

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