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The Situation:

Liver cancer is a leading cause of cancer deaths worldwide.1 Early detection facilitates a greater chance of survival.2 If detected early, the 5 year survival rate increases from 15% up to 70% with appropriate interventional treatment.3

The Challenge:

Surveillance programs facilitate earlier cancer detection, earlier access to curative treatments and greater patient survival.2 46% of enrolled patients in surveillance programs had significant increases in 5 year survival due to early tumor detection.4

How We Help:

Enhance Liver Cancer Surveillance using FUJIFILM’s AFP-L3 and DCP tests

AFP-L3 and DCP are in vitro diagnostic serum biomarkers

AFP-L3: Lectin-reactive alpha-fetoprotein; DCP: Des-gamma-carboxy prothrombin

AFP-L3% > 10%: Associated with 10.6-fold increased risk of developing HCC5

DCP > 7.5 ng/mL: Associated with 4.8-fold increased risk of developing HCC5

Both biomarkers are commercially available through major US reference labs and are available for reimbursement
by Centers for Medicare & Medicaid Services (CMS)


Overview of Intended Uses (See package inserts): The μTASWako AFP-L3 and DCP test systems are in vitro devices that consist of reagents used with the μTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, AFP-L3% and DCP in human serum. Both devices are intended for IVD use as aids in the risk assessment of patients with chronic liver disease for development of HCC in conjunction with other laboratory findings, imaging studies and clinical assessment.5

PHYSICIANS
  • Enhance HCC Surveillance with FUJIFILM serum biomarkers AFP-L3 and DCP

  • Risk assessment aids in early diagnosis, intervention and improved patient outcomes6-11.

  • HCC risk biomarkers are available from major US Reference labs

  • For in vitro diagnostic use

  • CMS reimbursed

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Laboratories
  • Fully Automated µTASWAKO i30 immunoassay Instrument

  • Superb analytical sensitivity

  • Innovative microfluidic, electrophoretic, and immunologic technology

  • Short setup time and optimized workflow design

  • Small Benchtop footprint (20.5 in W x 23.5 in D x 21.5 in H)


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The FUJIFILM μTASWako i30 System is designed for use with the μTASWako AFP-L3 and DCP tests to aid in HCC early detection.

uTASWako i30 593A3804-1
  • The test systems for in vitro diagnostic use for HCC risk assessment.
  • The μTASWako i30 immunoanalyzer offers speed, precision and sensitivity within an easy-to-use automated platform.
  • Fully automated system for in vitro diagnostic use
  • Automated sample-reagent mixing on single-use, disposable chip
  • Throughput: 25 results per hour
  • ~2-hour walk-away time
  • Optimized workflow design for efficiency and productivity
  • Microfluidics automate clinical lab processes
  • Bench-top footprint (20.5 inch W x 23.5 inch D x 21.5 inch H; and 150 lbs)
  • STAT functionality available
  • LIS connectivity

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FEATURED VIDEOS

Dr. Yang: Section 1

Dr. Charlton: Case Base HCC Screening & Surveillance

View More Videos

Demonstrated Clinical Utility While Attending The Liver Meeting Digital Experience™ 2021

Oral Presentation

Publication Number: 138
Session Title: Parallel 20: Hepatobiliary Neoplasia: Clinical Oral Session
Date and Time: Sunday, November 14, 2021, 4:00 PM
Talk Title: GALAD Score Improves Early Detection of HCC Prior to the Diagnosis of HCC: A Phase 3 Biomarker Validation Study
Authors: Marrero JA, Marsh TL, Parikh ND, Roberts LR, Schwartz ME, Nguyen M, Befeler A, Page-Lester S, Winick J, Vecchio M, Wagner P, Srivastava S, Rinaudo J, Singal AG, Feng Z,
Reddy RK.

Poster Presentation

Publication Number: 1462
Session Title: Liver Transplantation and Liver Surgery: Immunosuppression, Outcomes, and Complications
Poster Title: A COMBINATION OF AFP-L3 AND DCP PREDICTS HCC RECURRENCE AFTER LIVER TRANSPLANT: RESULTS OF A PROSPECTIVE STUDY
Authors: Joshua Norman (presenting), Dr. Prashant Kotwani, Dr. Francis Yao, Dr. Neil Mehta (corresponding)

Publication Number: 1174
Poster Title: PERFORMANCE CHARACTERISTICS OF THE GALAD SCORE IN ESTIMATING RISK OF HEPATOCELLULAR CARCINOMA: A SYSTEMATIC REVIEW AND META-ANALYSIS
Authors: Dr. Umesha Boregowda (presenting), Dr. Robert J. Wong, Dr. Doan Dao,Prof. Philip Johnson, Ms. Rupinder Mann, Dr. Robert G. Gish (corresponding)

References:

  1. American Cancer Society. Key Statistics About Liver Cancer. American Cancer Society, Atlanta, GA, USA, 2018. Available online at: www.cancer.org/cancer/liver-cancer/about/what-is-key-statistics.html
    (accessed on 2021-Aug-10)
  2. Singal AG, et al. “Early detection, curative treatment, and survival rates for hepatocellular carcinoma surveillance in patients with cirrhosis: a meta-analysis.” PLoS Med. 2014; 11(4):e1001624
  3. Siegel R, et al. “Cancer statistics, 2013.” CA Cancer J Clin. 2013 Jan; 63(1):11-30
  4. Zhang BH, et al. “Randomized controlled trial of screening for hepatocellular carcinoma.” J. Cancer Res. and Clin. Onc. 2004; 130:417–422
  5. µTASWako i30 Analyzer and AFP-L3 & DCP Test Systems Package Inserts
  6. Parikh, et al. “Biomarkers for the Early Detection of Hepatocellular Carcinoma.” Cancer Epidemiol Biomarkers Prev. 2020; 29:2495–503
  7. NCI. National Expenditures for Cancer Care; National Institutes of Health, National Cancer Institute: Bethesda, MD, USA, 2017. Available online: https://costprojections.cancer.gov/expenditures.html
    (accessed on 28 May 2017)
  8. NCI. Average Annual Costs of Care; National Institutes of Health, National Cancer Institute: Bethesda, MD, USA, 2017. Available online: https://costprojections.cancer.gov/annual.costs.html
    (accessed on 28 May 2017)
  9. Kakushadze, et al. “Estimating Cost Savings from Early Cancer Diagnosis.” MDPI 4. 2017. Available online: https://www.mdpi.com/2306-5729/2/3/30/pdf
  10. Kaplan, et al. “Healthcare Costs Related to Treatment of Hepatocellular Carcinoma Among Veterans With Cirrhosis in the United States.” Clin Gastroenterol Hepatol. 2018 Jan;16(1):106-114.e5
  11. Cadier B, et al. “Early detection and curative treatment of hepatocellular carcinoma: A cost-effectiveness analysis in France and in the United States.” Hepatology. 2017; 65(4):1237-1248

Contact Us

Please contact us for further inquiries of FUJIFILM's liver biomarkers AFP-L3 and DCP and uTASWako i30 system.

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