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HCC Risk Biomarker

DCP Test

Enhance Liver Cancer Surveillance
using AFP-L3 and DCP tests

CONTACT FUJIFILM IVD

Des-gamma-carboxy prothrombin (DCP) is a serum biomarker, also known as protein induced by vitamin K absence or antagonist-II (PIVKA-II). An increase in expression of this protein indicates a higher risk for development of hepatocellular carcinoma (HCC). Adding DCP to your current surveillance practice for HCC could increase your chances of detecting early HCC.

Clinical Significance

  • Elevated DCP values (>=7.5 ng/ml) has been shown to be associated with a 4.8-fold increased risk of HCC development in chronic liver disease patients (“μTASWako DCP Package Insert” (PDF)).
  • The American Association for the Study of Liver Disease (AASLD) recommends surveillance using ultrasound every 6 months for patients in high-risk groups [1]. High risk groups for HCC development are defined as patients with the chronic liver disease conditions of cirrhosis and certain patient groups with hepatitis B infection (even if without cirrhosis) [1].
  • DCP is a serum biomarker independent from AFP-L3 and AFP for HCC risk assessment. The elevation of both AFP-L3 and DCP indicate progression of HCC [2].
  • The Japan Society of Hepatology recommends the use of ultrasound and biomarkers, including AFP-L3, AFP and DCP, for HCC surveillance practice. Patients who have an elevation in any of the HCC risk biomarkers should be closely monitored by enhanced imaging modalities [3].
  • Simultaneous testing for DCP and AFP-L3 is complementary and effective for the early detection of HCC through surveillance and risk assessment [4].
  • FUJIFILM Wako’s fully automated immunoanalyzer, μTASWako i30, is for in vitro diagnostic use and provides parallel measurements for both AFP-L3 and DCP.

LEARN AFP-L3 Test

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.

AFP-L3 and DCP Tests Are Available
in the United States and Canada

Both DCP and AFP-L3 tests are available at major reference laboratories in the United States and are CMS reimbursed. Please contact Wako Diagnostics for more information on how to order the tests in Canada.

CPT code
AFP-L3 82107
DCP 83951

 

Characteristics

  • DCP is a precursor form of prothrombin, a coagulation protein.
  • In normal liver, prothrombin undergoes post-translational carboxylation before release into the peripheral blood. The carboxylation converts specific amino-terminal glutamic acid residues to gamma-carboxyglutamic acid.
  • The vitamin K dependent carboxylase responsible for the carboxylation is absent in many HCC cells, and an abnormal prothrombin with all or some of unconverted glutamic acid is secreted instead. Therefore, the non-carboxylated form (DCP) has been used as an HCC biomarker [5,6].

ff_dcp_molecule

References

  1. Bruix J, Sherman M. Management of Hepatocellular Carcinoma: An Update. Hepatology. 2011;53:1020-2.
  2. Toyoda H, et al. Diagnosis of hepatocellular carcinoma using a GALAD model by objective clinical and serological factors. The Liver Meeting® 2013 Poster 2112 [cited 24 Jan 2014]. http://www.wakodiagnostics.com/ documents/diagnosis_of_hepatocellular_carcinoma_using_a_galad_ model_by_objective_clinical_and_serological_factors_by_toyoda_ presented at the_liver_meeting_2013.pdf
  3. Makuuchi M, et al. Development of evidence-based clinical guidelines for the diagnosis and treatment of hepatocellular carcinoma in Japan. Hepatol Res. 2008;38:37-51.
  4. 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.
  5. 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.
  6. 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.