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Cancer research

Fujifilm's Biomarkers in Liver Cancer Screening Trial Gets National Cancer Institute Funding

Strategic Insights

— 2 min read

The National Liver Cancer Screening Trial (TRACER) has selected Fujifilm's AFP-L3 and DCP in vitro diagnostic tests to evaluate their effectiveness in detecting liver cancer in patients with cirrhosis or chronic hepatitis B. This trial is a significant step towards developing more accurate and early-stage liver cancer detection methods. Liver cancer, specifically hepatocellular carcinoma (HCC), is a rapidly growing cause of cancer deaths in the US, with 29,752 new cases estimated in 2023, according to the International Agency for Research on Cancer.

Key Takeaways:

  • The TRACER study aims to enroll 5,500 at-risk patients across 15 sites in the US, with each participant randomly assigned to either the standard of care (ultrasound and AFP) or the GALAD model, which incorporates Fujifilm's biomarker tests.
  • The primary outcome of the study is to reduce the proportion of late-stage HCC diagnosis, and secondary outcomes include measuring psychological and financial harms using validated patient surveys.
  • Fujifilm's biomarker tests, AFP-L3 and DCP, have shown promise in improving early diagnosis capabilities in recent studies, including the HCC Early Detection Strategy (HEDS) Study.
  • The GALAD score, a model derived from biomarkers such as AFP-L3 and DCP, has been studied in the TRACER trial, with a significant improvement in detecting early-stage HCC.
  • Henry Izawa, president and CEO of Fujifilm Healthcare Americas Corporation, emphasized the importance of the TRACER study in highlighting the benefits of HCC-specific blood tests in early-stage detection and treatment options.

Statistics:

  • Estimated 29,752 new cases of liver cancer (hepatocellular carcinoma) in the US in 2023 (Source: International Agency for Research on Cancer; Ferlay et al. 2024).
  • 5,500 patients to be enrolled in the TRACER study (Source: Press Release).
  • 15 sites participating in the TRACER study in the US (Source: Press Release).
  • 5 years to complete the TRACER study, with an active recruitment period of 3 years and data assessment at year 5 (Source: Press Release).
  • 70,000 employees globally in the FUJIFILM Holdings Corporation (Source: Company website).

Sources:

1. Press Release: Fujifilm's biomarker tests to be used in the National Liver Cancer Screening Trial (TRACER) - https://www.businesswire.com/news/home/20250618588663/en/

2. Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, et al. 2024. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today, accessed [11 April 2025].

3. Hanif H, Ali MJ, Susheela AT, Khan IW, Luna-Cuadros MA, et al. 2022. Update on the applications and limitations of alpha-fetoprotein for hepatocellular carcinoma. World J Gastroenterol 28(2):216-229, PMID: 35110946.

4. Yang JD, Addissie BD, Mara KC, Harmsen WS, Dai J, et al. 2018. GALAD score for hepatocellular carcinoma detection in comparison with liver ultrasound and proposal of GALADUS score. Cancer Epidemiol Biomarkers Prev 28(3):531-538, PMID: 30464023.

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