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Featuring: Jeffrey Winick, director, clinical affairs for In-Vitro Diagnostics, FUJIFILM Healthcare Americas Corporation
The liver is a big deal. It’s the largest solid organ in the body, and it performs over 500 functions. Talk about a multi-tasker!
At Fujifilm, we’re committed to looking after livers. We do so by innovating diagnostic solutions for liver cancer, like in vitro diagnostic (IVD) biomarkers for hepatocellular carcinoma (HCC) risk assessment. Off the heels of Liver Cancer Awareness Month and leading up to AASLD’s 2025 The Liver Meeting— the largest, annual scientific conference focused on liver diseases, we talked with Jeffrey Winick, director of clinical affairs for In-Vitro Diagnostics at FUJIFILM Healthcare Americas Corporation to explore the latest in liver cancer detection and Fujifilm’s advancements in the field.
Winick: Liver cancer is growing in prevalence across the globe. More than 800,000 people throughout the world are diagnosed with it each year. There are several different types of liver cancers, with HCC—cancer that arises from liver cells—being the most common.
HCC is the third leading cause of cancer-related mortality worldwide and it’s also the most rapidly growing cause of cancer deaths in the U.S. In 2025 alone, the American Cancer Society estimates about 42,240 new cases and 30,090 deaths in the U.S. from HCC and intrahepatic bile duct cancer. Here at home, liver cancer incidence rates has more than tripled since 1980, while the death rates have more than doubled. With statistics like that, the importance of early detection is critical because patients have more treatment options—and lives can be saved—when liver cancer is diagnosed at an early stage.
Winick: Researchers are working to advance our understanding of how to prevent, detect, and treat liver cancer. Over the past decade, new drugs and technologies have revolutionized treatment, particularly for advanced or inoperable liver cancer. Today’s treatment options include immunotherapy and targeted therapies based on precision medicine. To offer some perspective, until 2020 clinicians only had one approved drug for HCC, and now there are approximately ten.
When diagnosed at an early stage, patients with liver cancer have a good chance of survival with surgery, liver transplantation, or treatment. Biomarkers that serve as a sign of the disease are key. Scientists are working to find biomarkers in blood, urine, or other body fluids that are reliable signs of early-stage liver cancer. And that’s where Fujifilm comes in. Our In Vitro Diagnostics division offers FDA-cleared AFP-L3 and DCP biomarker tests that are utilized as an aid in HCC risk assessment in conjunction with other laboratory findings, imaging studies, and clinical assessment.
Winick: Unlike mammography or colonoscopy, there are no screening tests for people at average risk for liver cancer. Rather, screening is recommended for people at higher risk—those with cirrhosis, hereditary hemochromatosis, or chronic hepatitis B infection, for example. For detection of HCC, experts often recommend screening with alpha-fetoprotein (AFP) blood tests in combination with ultrasound every six months. However, ultrasound sensitivity can be compromised by the severity and underlying cause of liver disease, and serum AFP levels can be affected by several factors—compromising early-stage HCC diagnostic accuracy.
But another problem impacting early detection is that people don’t always comply with surveillance twice a year. A 2021-2022 study of 5 medical centers in the U.S. looked at HCC surveillance patterns in cirrhosis patients and found that surveillance was underused in more than 80% of patients. Only 1 in 7 patients received semiannual surveillance and 1 in 4 patients received annual surveillance. One of the challenges is getting patients to schedule—and sometimes travel a long distance—for an ultrasound exam.
Advances in biomarker research have made it possible to assess the risk for the development of HCC in patients with chronic liver disease. The use of biomarkers through a blood draw and a GALAD score can help with compliance as it’s much easier to go to any local lab and physicians obtain results quickly. Discovering biomarkers that can help improve patient care is a primary goal of Fujifilm. Biomarkers can contribute to early detection of HCC as well as help assess risk of developing HCC and the response to a particular treatment plan.
Winick: Presently, the use of Fujifilm’s AFP-L3 and DCP in vitro diagnostic tests is being evaluated in the National Liver Cancer Screening Trial (known as TRACER), a study funded by the National Cancer Institute, part of the National Institute of Health. The multi-center study compares liver cancer screening strategies in patients with cirrhosis or chronic hepatitis B.
The use of serum biomarkers like Fujifilm’s AFP-L3 and des-gamma-carboxyprothrombin (DCP) in surveillance can significantly improve early diagnosis capabilities, and the GALAD scoreiii – derived from Gender, Age, AFP-L3, AFP and DCP – has shown promise as a more accurate model for screening and early detection of HCC in at-risk patients in other recent studies.
The GALAD model continues to be evaluated in the TRACER study. The Phase IV prospective validation study, which began enrollment in January 2024 and is being conducted in the U.S., will enroll 5,500 at-risk patients across 17 sites including UPenn, Northwestern, Stanford, Indiana University, Michigan, and other renowned institutions.
Patients will be randomly assigned semi-annual screening with ultrasound ± AFP arm (the standard of care) or semi-annual screening via the GALAD model. Patients will be actively recruited over a 3-year period, with assessment of the data at year 5.5—in 2029. The primary aim is a reduction in the proportion of late-stage HCC diagnosis. Our hope is that this study will highlight the benefits of HCC-specific blood tests in the detection of early-stage HCC, so patients can have more treatment options and better outcomes.
Winick: At the meeting, we will discuss Fujifilm’s vitro diagnostic (IVD) biomarkers like AFP-L3 and DCP for hepatocellular carcinoma (HCC) risk assessment. These biomarkers contribute to the early detection, diagnosis, and management of liver diseases, including HCC, by providing clinicians with advanced methods for liver assessment. Attendees are invited to visit Fujifilm at Booth #522.