HCC Biomarkers

AFP-L3 and DCP

HCC Biomarkers

Wako's HCC 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].

HCC Biomarkers Increase Your Chances of Detecting Early HCC in Surveillance

  • Several studies have shown that the clinical utility of the HCC 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 liver@wakousa.com
  • Laboratories can measure serum levels of AFP-L3 and DCP with a single serum sample on a single analyzer, μTASWako i30 [5,10].

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.

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).

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.


Meetings

TLM 2017
The Liver Meeting
Oct 20-24, 2017
Washington, DC
Booth #328