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Driving diagnostic decisions along the continuum of chronic liver diseases
Impacting the way liver cancer can be prevented, diagnosed, treated, and monitored
Liver cancer is now the sixth most common cancer globally, and it is estimated that numbers will continue to rise.1,2 Hepatocellular carcinoma (HCC) accounts for 85-90% of primary liver cancer cases, and unfortunately, the majority of diagnoses occur in the late stages of disease.3,4 This results in an overall survival rate of less than 16% after five years, with the number of deaths from liver cancer predicted to rise from 760,000 in 2022, to 1.37 million in 2050.4,5
Roche is committed to focusing on liver cancer diagnosis, treatments, and surveillance approaches. Along with the investment in our broad menu of immunoassays to detect Hepatitis C virus (HCV) and Hepatitis B virus (HBV), we are constantly working to develop novel integrated solutions to help identify liver fibrosis in patients before they are at risk of developing HCC. By combining established immunoassays with automated software solutions, we support timely treatment and enable confidence in life-changing decisions.6-10
Hepatocellular carcinoma (HCC) is a “silent killer”
Despite 90% of cases being preventable, liver disease is a leading cause of mortality around the world.11,12 Undetected, this disease can silently progress to HCC, the most common form of liver cancer.13,14 In 2022, globally, there were 684,659 new HCC cases and 597,434 deaths.15 If something doesn’t change, it is predicted that deaths from liver cancer could rise by more than 55% by 2040.2
Key risk factors of liver cancer include HBV and HCV, heavy alcohol use, aflatoxin, and metabolic dysfunction-associated steatotic liver disease (MASLD).16,17
Metabolic liver diseases: The emerging leading cause of HCC
Metabolic dysfunction-associated steatotic liver disease (MASLD) represents a significant global health threat and challenge, and it is one of the leading causes of liver-related morbidity and mortality.18 MASLD is projected to become the leading cause of HCC in many countries.19
In 2015, the incidence of MASLD in the general population was around 15%, but today 38% of all adults, and 7-14% of children have the disease.20,21 The presence of MASLD is closely linked to type 2 diabetes (T2D), obesity, and other cardiometabolic risk factors.20 The diagnostic criteria for MASLD require the presence of hepatic steatosis along with at least one metabolic risk factor, such as obesity, type 2 diabetes, or components of metabolic syndrome.20,22
Unlocking earlier detection
Worldwide, a high proportion of chronic hepatitis infections remain undetected. It’s estimated that 79% of HCV and 90% of HBV infections remain undiagnosed.23 Moreover, approximately 5% of the general population without known liver disease, and 18% to 27% of populations with risk factors for liver disease, have significant undetected liver fibrosis or established cirrhosis.17
Unfortunately, clinicians still face challenges in diagnosing liver cancer at early stages before it progresses to hepatocellular carcinoma and only 20 to 43% of liver cancer patients are diagnosed at an early stage.24-27 Cost-effectiveness of screening and detection of advanced fibrosis or cirrhosis are improved when non-invasive screening is introduced in routine clinical practice, leading to reduction in unnecessary referrals from primary to secondary care by 90%.17,28,29
Early diagnosis of fibrosis and subsequent appropriate management can potentially prevent progression to cirrhosis and its complications and may justify screening in these populations at risk.20
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Benefits of Roche diagnostic solutions for managing and diagnosing chronic liver diseases
Untangling patient data into more precise care
Roche is the oncology and digital solutions partner that continuously invests in scientific innovation, rising to meet the opportunities and challenges of chronic liver disease path, today and in the future.
Our pioneering solutions and technologies are transforming the way chronic liver diseases can be detected, enabling physicians to predict a disease's prognosis and to make a more informed decision about treatment options for patients.
Currently, people at high risk of developing liver cancer may undergo ultrasound examinations, which can detect early-stage hepatocellular carcinoma with a sensitivity of 45%. Combining ultrasound with alpha-fetoprotein (AFP) blood tests for protein levels can increase early-stage detection by 18%. 30
At Roche, we are shaping a new class of diagnostic algorithms, engineered to further increase sensitivity for detecting early and all stages of hepatocellular carcinoma:
- A simple and yet sophisticated navify® algorithm (GAAD) draws on specific biomarker assays (PIVKA-II and AFP) and clinical parameters like gender and age, and can enhance sensitivity from 42% with ultrasound alone, to approximately 70% with ultrasound + GAAD.31
- The navify® algorithm GAAD score can be easily calculated based on patient demographics and the measurement of blood-based tumor markers using a small volume of blood.32,33
For severity assessment of hepatic fibrosis in patients showing signs or evidence of MASLD, Roche brings to the market a non-invasive, precise, and fast solution by combining Elecsys® Pro-C3 immunoassay and ADAPT, a navify® algorithm by Evidencio.10, 34
Roche is committed to advancing science so that healthcare professionals can unlock access to patients with chronic liver diseases for accurate treatment decision-making.
Early diagnosis offers a better chance for a cure
For people suffering from chronic liver diseases (CLD), time is crucial, and patients can’t wait. Roche focuses on unmet needs along the continuum of CLD with solutions to accelerate answers across the entire patient journey. From hepatitis screening to HCC surveillance, we are committed to providing a broad range of solutions to help clinicians achieve better patient outcomes.
Our hepatitis immunoassays portfolio is constantly growing to identify patients with hepatitis, so they can get the right treatment and ultimately prevent further development into liver fibrosis, cirrhosis, and liver cancer.
For patients with chronic liver disease, and recommended for surveillance due to increased risk of developing HCC, the navify® GAAD algorithm helps to facilitate quicker and more accurate evaluation for patients.
Disrupting the continuum of CLD
Roche is fostering long-term collaborations with the oncology community, aiming to help more patients be diagnosed earlier along the CLD continuum of care.
We amplify impact, investing in future-proof diagnostics capabilities and integrated solutions, so clinicians and our customers can continue the global fight against liver cancer. By providing reliable data allied to useful resources and partnerships, we join the mission to stop the progression of chronic liver diseases, disrupt the trajectory into liver cancer, and ultimately save lives.
Together, we can disrupt the progression from chronic liver disease to liver cancer.
The lab of the future: Clinical decision support for liver cancer
Discover how Prof. Dr. med. Julia-Stefanie Frick and PD Dr. Nils Stührwohldt leverage digital biomarkers to revolutionize chronic liver disease care. Watch now!
The silent epidemic: What you need to know about MASLD
Join Prof. Dr. Jörn Schattenberg to uncover the silent threat of MASLD and learn how early detection saves lives. Watch now!
Explore more
References
WHO. Liver and Intrahepatic Bile Ducts Fact Sheet [Internet; cited 2026 Aug 27]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/11-liver-and-intrahepatic-bile-ducts-fact-sheet.pdf.
IARC. Number of new cases and deaths from liver cancer predicted to rise by more than 55% by 2040 [Internet; cited 2026 Aug 27]. Available from: https://www.iarc.who.int/wp-content/uploads/2022/10/pr320_E.pdf.
El-Serag HB and Davila JA. Surveillance for hepatocellular carcinoma: in whom and how? Therapeutic advances in gastroenterology. 2011;4(1):5–10.
Tsuchiya N, et al. Biomarkers for the early diagnosis of hepatocellular carcinoma. World J Gastroenterol. 2015;21(37):10573-83.
ASCO Post. Three in Five Liver Cancer Cases May Be Due to Preventable Risk Factors, The Lancet Commission Finds [Internet; cited 2026 Aug 27]. Available from: https://ascopost.com/news/july-2025/three-in-five-liver-cancer-cases-may-be-due-to-preventable-risk-factors/.
F. Hoffmann-La Roche Ltd. Elecsys HVC Duo. Method Sheet. (v4.0). 2025.
F. Hoffmann-La Roche Ltd.Elecsys Anti-HBc II. Method Sheet. (v4.0). 2023.
F. Hoffmann-La Roche Ltd. Elecsys HBeAg Quant. Method Sheet. (v2.0). 2025.
F. Hoffmann-La Roche Ltd. Elecsys HBsAgII. Method Sheet. (v5.0). 2025.
F. Hoffmann-La Roche Ltd. Elecsys PRO-C3. Method Sheet. (v2.0). 2025.
British Liver Trust. [Internet; cited 2026 Aug 27]. Available from: https://britishlivertrust.org.uk/information-and-support/statistics/#prevention.
Gan C, et al. Liver diseases: epidemiology, causes, trends and predictions. Sig Transduct Target Ther. 2025;10;33.
McGlynn KA, et al. Epidemiology of Hepatocellular Carcinoma. Hepatology. 2021;73(Suppl 1):4–13.
Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71:209–49.
Ping L, et al. Global, regional, and national burden of hepatocellular carcinoma and contribution of nine modifiable risk factors across 185 countries/territories in 2022. Sci Bull. 2026;71(4):838-49.
American Cancer Society. Liver Cancer Risk Factors. [Internet; cited 2026 Sept 9]. Available from https://www.cancer.org/cancer/types/liver-cancer/causes-risks-prevention/risk-factors.html.
Ginès P, et al. Population screening for liver fibrosis: Toward early diagnosis and intervention for chronic liver diseases. Hepatology. 2022;75:219–28.
Zheng H, et al. Metabolic dysfunction-associated steatotic liver disease and cardiovascular risk: a comprehensive review. Cardiovasc Diabetol 2024; 23, 346.
Ioannou GN. Epidemiology and risk-stratification of NAFLD-associated HCC. J Hepatol. 2021;75(6):1476–84.
EASL. Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). J Hepatol. 2024; 81(3):492-542.
Younossi ZM et al. Epidemiology of metabolic dysfunction-associated steatotic liver disease. Clin Mol Hepatol. 2025;31:e145.
Hong S, et al. From NAFLD to MASLD: When metabolic comorbidity matters. Annals of Hepatology. 2024;29(2):101281.
WHO. Viral hepatitis B and C policies in countries and burden of disease in WHO regions Fact Sheet [Internet; cited 2026 Aug 27]. Available from: https://cdn.who.int/media/docs/default-source/hq-hiv-hepatitis-and-stis-library/hepatitis-factsheet_2023.pdf.
Llovet J, et al. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021;7:6.
Cancer.net. Key Statistics About Liver Cancer. [Internet; cited 2026 Aug 27]. Available from: https://www.cancer.net/cancer-types/liver-cancer/statistics.
CCO. Features and treatment options of Chinese hepatocellular carcinoma. [Internet; cited 2026 Aug 27]. Available from: https://cco.amegroups.com/article/view/2865.
Yildirim HC, et al. Advances in the Early Detection of Hepatobiliary Cancers. Cancers (Basel). 2023;15(15):3880.
Serra-Burriel M, et al. Transient elastography for screening of liver fibrosis: Cost-effectiveness analysis from six prospective cohorts in Europe and Asia. J Hepatol. 2019;71(6):1141–51.
Thiele M, et al. Accuracy of the Enhanced Liver Fibrosis Test vs FibroTest, Elastography, and Indirect Markers in Detection of Advanced Fibrosis in Patients With Alcoholic Liver Disease. Gastroenterology. 2018;154(5):1369–79.
Tzartzeva K, et al. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018;154(6):1706-1718.e1.
Huang CF, et al. Surveillance Imaging and GAAD/GALAD Scores for Detection of Hepatocellular Carcinoma in Patients with Chronic Hepatitis. J Clin Transl Hepatol. 2024;12(11):907-916.
F. Hoffmann-La Roche Ltd. Elecsys AFP-L3. Method Sheet. (v2.0). 2025.
F. Hoffmann-La Roche Ltd. Elecsys PIVKA-II. Method Sheet. (v2.0). 2023.
Brouwer WP, et al. Steatotic liver disease trajectory: A holistic EASL guidance on the multidisciplinary approach to screening and patient management. JHEP Rep. 2026;8:101798.