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HCC Risk Biomarkers

Aiding in the Early Detection of HCC
μTASWako® AFP-L3 and DCP

Aiding in the Early Detection of Hepatocellular Carcinoma

 

FUJIFILM Wako’s HCC risk biomarkers AFP-L3 and DCP are intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of HCC.

The serum biomarkers lectin-reactive alpha-fetoprotein (AFP-L3) and des-gamma-carboxy prothrombin (DCP) have been shown to be specific to hepatocellular carcinoma (HCC) and their combined use aids in clinical assessment for early detection. Adding the two biomarkers, AFP-L3 and DCP, to your current HCC surveillance practice can increase your chances of detecting early HCC. These tests are available now in the United States and Canada.

HCC Surveillance Improves Patient Outcome

Early detection of HCC is crucial for the application of curative therapies and improving patient outcome. HCC surveillance is a widely recommended practice for early detection of HCC.

  • The incidence of HCC is increasing worldwide. HCC is the second leading cause of cancer related death in the world. It is the fifth leading cause of cancer for men and the ninth for women [1].
  • At-risk patients for HCC development are highly encouraged to enroll in HCC surveillance programs for early detection of HCC. The American Association for the Study of Liver Diseases (AASLD) identifies patients with cirrhosis and patients with chronic hepatitis B infection (even if without cirrhosis) as being at high risk for HCC development [2].
  • Early detection of HCC is crucial for the application of curative therapies and improving patient outcome. HCC surveillance improves long-term, tumor-free survival of HCC patients receiving early treatment [3].

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HCC Risk Biomarkers Increase Your Chances of Detecting Early HCC in Surveillance

  • Several studies have shown that the clinical utility of the HCC risk biomarkers is improved when using the biomarkers in combination [4-9]. The biomarkers AFP-L3 and DCP are complementary and have been shown to be effective for the early detection of HCC.
  • The combined use of these tests is currently available and can be ordered with a single test code at most major reference laboratories in the United States. For information on how to order the tests in Canada, please contact at Customer Service
  • Laboratories can measure serum levels of AFP-L3 and DCP with a single serum sample on a single analyzer, μTASWako i30 [5,10].

μTASWako® AFP-L3 Test

For in vitro diagnostic (IVD) use and CMS reimbursed.

AFP-L3 is an isoform of AFP, which is a glycoprotein normally produced by fetal liver. In adults, an increase in the concentration of this protein can be indicative of primary liver cancer and germ cell tumors. AFP-L3 has been reported to be more specific than total AFP or other AFP isoforms in patients with HCC [11]. The AFP-L3 test represents the ratio of AFP-L3 to total AFP as a percentage. Elevated AFP-L3 values (>=10%) have been shown to be associated with a 10.6-fold increased risk of developing HCC within the next 21 months.

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μTASWako® DCP Test

For in vitro diagnostic (IVD) use and CMS reimbursed.

DCP is an immature form of the coagulation protein, prothrombin, which can be indicative of the presence of HCC cells [12]. Elevated DCP values (>=7.5 ng/ml) have been shown to be associated with a 4.8-fold increased risk of developing HCC. DCP is also known as Protein Induced by Vitamin K Absence or Antagonist-II (PIVKA-II).

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For Clinical Laboratories

 

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μTASWako® i30
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μTASWako® AFP-L3
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μTASWako® DCP
FF_μTAS Wako i30 Product Photo

μTASWako® i30 Test System

For In Vitro Diagnostic Use

Automated Platform
microfluidic-based clinical immunoanalyzer

The μTASWako i30 is a commercially available microfluidic-based clinical immunoanalyzer for in vitro diagnostic use in the United States and Canada. The microfluidic technology minimizes instrument hands-on time while maximizing efficiency through integration and automation of clinical laboratory processes. Currently FUJIFILM Wako is offering AFP-L3 and DCP tests on the μTASWako i30.

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μTASWako® AFP-L3

For In Vitro Diagnostic Use

Intended Use

The μTASWako AFP-L3 Immunological Test System is an in vitro device that consists of reagents used with the μTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, AFP-L3% in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies and clinical assessment. Patients with elevated AFP-L3% values (>= 10%) have been shown to be associated with an increase in the risk of developing HCC within the next 21 months and should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.

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FF_Wako-DCP-Reagents-740x470

μTASWako® DCP

For In Vitro Diagnostic Use

Intended Use

The μTASWako DCP Immunological Test System is an in vitro device that consists of reagents used with the μTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, des-gamma-carboxyprothrombin (DCP) in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies, and clinical assessment.

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FF IVD liver cancer surveillance for patients

For Chronic Liver Disease Patients

Liver cancer surveillance is the application of screening tests such as blood tests and ultrasonography at regular intervals, intended to identify liver cancer at an early stage in individuals who are at risk. Robust surveillance in high risk patients is critical to finding liver cancer in its early stage which is when more effective treatment options are available and can be applied with more success. The treatment options that are available for early stage liver cancer are associated with better long term outcomes.

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer. We will refer to it as liver cancer throughout this page.

  • Are you at risk of developing liver cancer?
  • Liver Cancer Surveillance
  • Liver Cancer Facts

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References

  1. World Health Organization, International Agency for Research on Cancer. GLOBOCAN 2012, Retrieved 14 Jan 2014 from http://globocan.iarc.fr
  2. Bruix J, Sherman M. Management of Hepatocellular Carcinoma: An Update. Hepatology. 2011;53:1020-2
  3. Stravitz RT, et al. Surveillance for hepatocellular carcinoma in patients with cirrhosis improves outcome. Am J Med. 2008;121:119-26.
  4. Ertle JM, et al. A Combination of a-Fetoprotein and Des-?-Carboxy Prothrombin Is Superior in Detection of Hepatocellular Carcinoma. Digestion. 2013;87:121-31.
  5. Choi JY, et al. Diagnostic value of AFP-L3 and PIVKA-II in hepatocellular carcinoma according to total-AFP. World J Gastroenterol. 2013;19:339-46.
  6. Arii S, et al. Management of hepatocellular carcinoma: Report of Consensus Meeting in the 45th Annual Meeting of the Japan Society of Hepatology (2009). Hepatol Res. 2010;40:667-85.
  7. Shimauchi Y, et al. A simultaneous monitoring of Lens culinaris agglutinin A-reactive alpha-fetoprotein and des-gamma-carboxy prothrombin as an early diagnosis of hepatocellular carcinoma in the follow-up of cirrhotic patients. Oncol Rep. 2000;7:249-56.
  8. Nomura F, et al. Serum des-gamma-carboxy prothrombin levels determined by a new generation of sensitive immunoassays in patients with small-sized hepatocellular carcinoma. Am J Gastroenterol 1999;94:650-4.
  9. Hann HW, et al. Usefulness of highly sensitive AFP-L3 and DCP in surveillance for hepatocellular carcinoma in patients with a normal alphafetoprotein. J Med Microb Diagn. 2014;3:130.
  10. Kagebayashi C, et al. Automated immunoassay system for AFP-L3% using on-chip electrokinetic reaction and separation by affinity electrophoresis. Anal Biochem. 2009;388:306-11.
  11. Sato Y, et al. Early recognition of hepatocellular carcinoma based on altered profiles of alpha-fetoprotein. N Engl J Med. 1993;328:1802-6.
  12. Liebman HA, et al. Des-gamma-carboxy (abnormal) prothrombin as a serum marker of primary hepatocellular carcinoma. N Engl J Med. 1984;310:1427-31.