Genetron Health Announces Results from Large-Scale Prospective Cohort Study of HCCscreen™, a Blood-Based Liquid Biopsy Test for Early-Stage Liver Cancer Detection

Genetron Holdings (NASDAQ: GTH), a global pioneer in precision oncology, focuses on cancer genomics research and applications. Committed to transforming cancer diagnosis and treatment through advanced molecular biology and big data analytics, the company provides early cancer screening products and develops companion diagnostic technologies. Today, it released the latest data on HCCscreen™, its blood-based early detection test for hepatocellular carcinoma.

The “HCCscreen™ Investigational Study” (HIT) is a multicenter, prospective study initiated by Genetron Holdings Limited and the National Cancer Center of China in 2019. As of February 2021, the company had completed follow-up for 1,615 patients who were positive for hepatitis B surface antigen. The data showed that HCCscreen™ achieved a sensitivity of 88% and a specificity of 93%, whereas ultrasound combined with alpha-fetoprotein (AFP) testing yielded a sensitivity of 71% and a specificity of 95%. HCCscreen™ also demonstrated a positive predictive value (PPV) of 40.9% and a negative predictive value (NPV) of 99.3%. The study results are summarized as follows:

Table 1. HIT Study Results: Final Analysis of Genetron HCCscreen™ (1,615 Patients)

Table 2. HIT Study Results: Final Analysis of Ultrasound Combined with Alpha-Fetoprotein Testing (1,615 Patients)

It is worth noting the findings stratified by tumor size. Among liver cancer patients diagnosed by HCCscreen™, 49% were in the early stage with tumors smaller than 3 cm, and these patients are expected to have a significantly better prognosis than those with advanced-stage disease. For tumors smaller than 3 cm, the sensitivity of HCCscreen™ was 85%; for tumors measuring 3–5 cm, the sensitivity was 96%.

Professor Qu Chunfeng, a researcher at the State Key Laboratory of Molecular Oncology, National Cancer Center, and Director of the Immunology Research Office, stated: “This prospective study was conducted under the support of the National Science and Technology Major Project for Infectious Diseases during the 13th Five-Year Plan period. We utilized HCCscreen™, a liquid biopsy method that combines cfDNA gene mutations, methylation, and protein biomarkers, to test 1,615 hepatitis B virus carriers. Overall, the results from this prospective cohort were satisfactory, demonstrating significant advantages over traditional detection methods, particularly in identifying early-stage hepatocellular carcinoma tumors smaller than 3 centimeters.”

Previously, Genetron Holdings Limited announced preliminary analysis data from 297 patients at one of the centers. The multicenter study data involving 1,615 patients, provided by Genetron today, showed that the confidence interval for sensitivity was optimized from the previous 62%–100% to 80%–94%, while the confidence interval for specificity was optimized from 89%–96% to 91%–94%.

Yang Xizhong, Executive Vice Chairman of the China Hepatitis Prevention and Control FoundationHe stated, “China has 86 million hepatitis B virus carriers and 28 million patients with liver disease, all of whom are at high risk for hepatocellular carcinoma (HCC). Screening high-risk populations is a crucial strategy for HCC prevention. Due to the lack of effective methods, approximately 80% of HCC cases are currently diagnosed at an advanced stage, missing the window for curative treatment. It is highly encouraging to note that the latest data from a prospective study jointly conducted by the National Cancer Center and leading enterprises in the field of precision medicine show that the sensitivity of HCC screening can reach as high as 88%. In particular, the sensitivity for early-stage HCC tumors smaller than 3 cm reaches 85%, significantly surpassing current conventional diagnostic techniques. As is well known, the median survival time for patients with early-stage HCC exceeds five years, far longer than the three months observed in end-stage HCC. We look forward to these latest HCC screening technologies being rapidly integrated into clinical practice to save more patients and families, making significant contributions to the realization of Healthy China 3.0!”

Xie Chengrun, Chairman of the Board of Chia Tai Tianqing Pharmaceutical GroupHe stated, “Since the strategic partnership was established at the beginning of this year, we have worked hand in hand with Genetron Holdings to rapidly promote clinical awareness and adoption of HCCscreen™, achieving initial success. Just last week, we witnessed an encouraging case: a patient with normal AFP levels and atypical imaging findings for hepatocellular carcinoma (HCC). HCCscreen™ testing returned a positive result, and subsequent postoperative pathological examination confirmed a 3-cm nodular hepatocellular carcinoma. According to international guidelines, this is classified as stage A, indicating a five-year survival rate of up to 90%. The outstanding performance of the prospective cohort data recently released by Genetron Holdings demonstrates that, as the Chia Tai Tianqing team rapidly expands its hospital market coverage, we will have the opportunity to save the lives of thousands of patients, allowing them to continue enjoying happy lives with their families. We are confident that our collaboration will quickly enter a period of robust growth.”

Zhang Ligang, Founder, Chairman and CEO of iKang GroupHe stated, “The future of health checkups will fully leverage innovative technologies such as big data, artificial intelligence, and precision medicine to achieve earlier detection, diagnosis, and treatment. In 2019, iKang introduced Genetron’s HCCscreen™ product, which has received the U.S. FDA ‘Breakthrough Device’ designation, for early screening of liver cancer. This decision was driven by our recognition of Genetron’s internationally leading proprietary liquid biopsy technology. Just before the Spring Festival this year, we detected a case of early-stage liver cancer with a tumor size under 3 cm in a patient only 45 years old, in the prime of his life. Thanks to timely detection and treatment, he may achieve a 90% five-year survival rate, allowing him to quickly return to work, daily life, and his family. The latest prospective cohort data released by the National Cancer Center and Genetron signifies a substantial increase in the detection rate of early-stage liver cancer. We believe that an era of health checkups powered by algorithmic medicine through innovative technology has arrived, bringing more precise medical examination services to the Chinese population.”

Wang Sizhen, Co-founder and CEO of Genetron Holdings Limitedstates: "Genetron Holdings Limited has been committed to tackling cancer, the foremost threat to human health, through the most efficient methods and technological breakthroughs. In the past two years, China’s early cancer screening industry has witnessed significant technological advancements, with numerous Chinese biotech innovators achieving global leadership in technology and product performance for specific cancer types. The latest data results for HCCscreen™ are highly encouraging, and our substantial progress in both clinical and commercial domains signifies that HCCscreen™ will benefit a broader patient population. We are honored to collaborate with leading research institutions, professional associations, and strategic partners in this vital endeavor closely linked to human health. To extend benefits to a wider population, Genetron will initiate the regulatory submission process for its liver cancer early screening kit in the second quarter of this year, accelerating the deployment of standardized, highly accessible, non-invasive, and precise early cancer screening products. Genetron is dedicated to working with the entire industry to leverage our superior technological capabilities and explore diverse pathways for industrialization, thereby contributing to the continuous advancement of precision medicine.

In September 2020, Genetron’s HCCscreen™️ received the “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) and has recently commenced commercialization in China as a laboratory-developed test (LDT).

Globally, liver cancer ranks fourth in cancer-related mortality and sixth in incidence [1]. China has the highest number of liver cancer cases worldwide, accounting for nearly half of the global total. Each year, there are approximately 393,000 new cases and about 369,000 deaths from liver cancer in China [2]. According to 2019 research data from Frost & Sullivan, China has approximately 120 million people at high risk for liver cancer, including about 74 million hepatitis B virus carriers.

The core technology of HCCscreen™ is derived from Genetron Holdings Limited’s proprietary innovative technology, Mutation Capsule™, which enables simultaneous detection of multiple methylation patterns and gene mutations in cell-free DNA from peripheral blood.

Genetron Holdings (NASDAQ: GTH) is a global leader in precision oncology, dedicated to advancing cancer genomics research and applications. The company is committed to transforming cancer diagnosis and treatment by leveraging advanced molecular biology and big data analytics. Genetron has established a comprehensive portfolio of products and services spanning the entire cancer care continuum—from early screening, diagnosis, and therapeutic recommendations to monitoring and prognostic management. In collaboration with partners across the industry value chain, Genetron is actively expanding innovative applications and scenarios for molecular testing technologies.

References

1.     Villanueva, A. Hepatocellular Carcinoma. N. Engl. J. Med. 2019, 380, 1450–1462.

2.    Globocan 2018. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Information on this website is not incorporated into this update and should not be considered part of this update. We have included any website as an inactive textual reference only.