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Genetron Health’s Liver Cancer Screening Results and Technology Findings Included in the Chinese Journal of Hepatology

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Genetron Holdings Limited (Nasdaq: GTH) announced significant recognition for its HCCscreen™ liver cancer screening product in the Chinese Journal of Hepatology. Clinical results from Genetron's HIT study indicated better performance than traditional methods, receiving endorsements from leading experts in hepatology and oncology. Two influential articles underscored HCCscreen™'s diagnostic value, emphasizing its potential for early detection of hepatocellular carcinoma (HCC). CEO Sizhen Wang highlighted the company's commitment to advancing early screening initiatives in China.

Positive
  • HCCscreen™ recognized in Chinese Journal of Hepatology for clinical efficacy.
  • HIT study shows better screening performance than AFP plus ultrasound.
  • Endorsements from top experts solidify HCCscreen™'s diagnostic capabilities.
  • FDA breakthrough device designation enhances product credibility.
  • Focus on early liver cancer screening aligns with Chinese government health initiatives.
Negative
  • None.

Innovative Technology of HCCscreen™ and Leading Prospective Data Well-Recognized by Expert Consensus

BEIJING, Oct. 28, 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 the clinical results and technology findings of its early liver cancer screening product for hepatocellular carcinoma (HCC), HCCscreen™, were included in the October 2021 publication of Chinese Journal of Hepatology (“the Journal”).

The Journal was established in 1993 as a publication under the Chinese Medical Association (CMA), covering etiology, epidemiology, pathology, immunology, pathogenesis, clinical diagnosis, and the treatment and prevention of various liver diseases. This peer-reviewed monthly journal has a strong editorial board that is composed of over 50 top Chinese hepatologists or specialists in associated fields. It is a prestigious publication in the liver disease medical community in China, and is viewed as having significant influence on clinical practice among physicians.

Two articles related to HCCscreen™ were included in the latest publication:

  • Expert consensus on the role of hematological markers in the early clinical screening of hepatocellular carcinoma (“the Expert Consensus”) – submitted by the Infectious Disease Prevention and Control Division of the Chinese Preventive Medicine Association (CPMA)
  • Expert-reviewed article on screening and surveillance of hepatocellular carcinoma in patients with chronic hepatitis B virus infection – submitted by the Chinese Foundation for Hepatitis Prevention and Control (CFHPC)

Authored and reviewed by about 50 experts in China, including chief physicians in hepatology, oncologists, epidemiologists and surgeons, both articles mentioned the breakthrough device designation for HCCscreen™, which was granted by the U.S. Food and Drug Administration. In addition, Genetron Health’s ctDNA-based technology approach, which combines methylation, mutation and protein markers for HCC in its assay, along with its 1,615 patient HIT study’s results¹, were included.

The Expert Consensus stated that HIT data showed “better screening performance than AFP plus ultrasound” and highlighted the diagnostic value of HCCscreen™ in identifying early-stage HCC.

For the expert-reviewed article, the CFHPC organized relevant domestic experts to review domestic and foreign guidelines, combining them with the latest research findings and clinical practice experience to reach an agreement. The aim was to provide a standardized reference to improve preventive control and effectiveness for HCC screening in patients with chronic HBV infections. The article suggested that a multi-omics strategy “could offer higher sensitivity and specificity than AFP” for early HCC screening and monitoring.

“Since our first major publication in the Proceedings of the National Academy of Sciences (PNAS) in 2019, we have made significant clinical and commercialization progress in advancing HCCscreen™. We are excited that our innovative approach and prospective study results were well-received by leading industry experts,” said Sizhen Wang, Genetron Health’s Co-founder and CEO. “Early screening, particularly for liver cancer, continues to be a focus for the Chinese government. Genetron Health will contribute to this initiative by developing easy-to-use, accurate, early screening tests, in order to save more lives and reduce cancer-related costs for patients and society.”

About Chinese Journal of Hepatology

The Chinese Journal of Hepatology was established in 1993 as a publication under the Chinese Medical Association (CMA), covering etiology, epidemiology, pathology, immunology, pathogenesis, clinical diagnosis, and the treatment and prevention of various liver diseases. This peer-reviewed monthly journal has a strong editorial board that is composed of more than 50 top Chinese hepatologists or specialists in associated fields. Among them, some are academicians of the Chinese Academy of Engineering. Since its establishment, articles published in the Chinese Journal of Hepatology have been listed in the CD edition of the Chinese Academic Journal, China Info, Chinese Articles Database of Biological Medicine, Digestology in the World, Index Medicus, Chemical Abstracts, Chinese Science and Technology Papers in Statistical Source and Chinese Science Citation Database.

About CFHPC

Established in 1996, CFHPC is a national public fundraising foundation. The entity focuses on the prevention and treatment of hepatitis, and improvement of overall public health in China. The foundation actively partners with other leading domestic and foreign government and academic organizations, including CMA, CPMA, WHO, American Association or the Study of Liver Disease (AASLD), etc. For more information, please visit: http://cfhpc.cn/

About the Infectious Disease Prevention and Control Division of CPMA

Founded in 1987, CPMA is a national, voluntary-based academic group organized by scientific and technology professionals in the public health and preventive medicine fields. CPMA is a direct affiliate and unit of the National Health Commission, and an integral part of the China Association for Science and Technology. The Infectious Disease Prevention and Control Division was established in 2018 to focus on prevention, diagnosis, and treatment for all infectious diseases including liver-related illnesses. For more information, please visit: http://www.cpma.org.cn/zhyfyxh/new_index.shtml

Reference:

  1. https://ir.genetronhealth.com/news-releases/news-release-details/genetron-health-releases-new-data-results-hccscreentm-liver

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, including statements regarding clinical and commercialization progress, clinical data, and outlook of HCCscreen™, 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
Genetron Health
Email: hoki.luk@genetronhealth.com
Phone: +1 (408) 891-9255

Media Relations
Yanrong Zhao
Genetron Health
yanrong.zhao@genetronhealth.com

Edmond Lococo
ICR
Edmond.Lococo@icrinc.com
Mobile: +86 138-1079-1408
genetron.pr@icrinc.com


FAQ

What are the clinical results of Genetron's HCCscreen™?

Genetron's HCCscreen™ demonstrated better screening performance than traditional methods in its HIT study, as highlighted in the Chinese Journal of Hepatology.

How was HCCscreen™ recognized in the Chinese Journal of Hepatology?

The journal included two articles on HCCscreen™, emphasizing its diagnostic value and effectiveness in early-stage detection of hepatocellular carcinoma.

What is the significance of FDA breakthrough device designation for GTH?

The FDA breakthrough device designation for HCCscreen™ enhances its credibility and highlights its potential impact on liver cancer screening.

How does Genetron plan to contribute to liver cancer screening in China?

Genetron aims to develop accurate, easy-to-use early screening tests for liver cancer, supporting initiatives by the Chinese government to improve early detection.

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