FUJIFILM Healthcare Americas Corporation, a leading provider of diagnostic and enterprise imaging solutions, announced today that use of its 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.
Hepatocellular cancer (HCC) is the third leading cause of cancer-related mortality worldwide and the most rapidly growing cause of cancer deaths in the U.S.i HCC mortality continues to escalate due to the increased prevalence of chronic liver diseases, inadequate diagnostic precision in the early stages of disease, and historical lack of effective systemic therapies for late-stage HCC. Surveillance of high-risk patients is typically conducted via liver ultrasound in combination with serum alpha-fetoprotein (AFP) serum testing. However, ultrasound sensitivity can be compromised by the severity and underlying cause of liver disease, and serum AFP levels can be affected by hepatic inflammation, patient characteristics, and hereditary and other non-hepatic disorders,ii among other factors, compromising early-stage HCC diagnostic accuracy.
The use of serum bio markers such as 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 recent studies, including the HCC Early Detection Strategy (HEDS) Study conducted through the EDRN (https://pubmed.ncbi.nlm.nih.gov/39293548/). FUJIFILM Healthcare Americas Corporation 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.
The GALAD model continues to be studied 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 15 sites that 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; the primary aim is a reduction in the proportion of late-stage HCC diagnosis. The TRACER study will measure secondary outcomes of interest including psychological and financial harms utilizing validated patient surveys.
“We are pleased that the TRACER study is evaluating the use of Fujifilm’s biomarker tests as a potential way to improve effectiveness in HCC screening in at-risk patients,” said Henry (Hidetoshi) Izawa, president and chief executive officer, FUJIFILM Healthcare Americas Corporation. “HCC is often diagnosed at an advanced stage, with limited treatment options. Our hope is that this study will further underscore the benefits of HCC-specific blood tests in the detection of early-stage HCC, and patients will benefit from earlier diagnosis and treatment options.”
