HCC Biomarkers

AFP-L3 and DCP

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HCC Biomarkers

HCC Serum Markers
AFP-L3 and DCP(PIVKA-II)

Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide with 626,000 new cases in 2002 [1]. Currently, HCC is the leading cause of death amongst cirrhotic patients [2], and the HCC incidence rate continues to rise in the United States [3]. Moreover, the overall HCC five-year survival rate during 1996-2004 was only 11.7% [4]. However, it has been shown that HCC surveillance program for at-risk patients improves applicability of curative therapies [5,6]. Therefore, early detection of HCC is paramount in improving HCC patient outcome. Incorporating Wako's HCC biomarkers as additional HCC surveillance tools will improve the chance of detecting HCC at early stages.

Wako's HCC Biomarkers

Wako's FDA cleared HCC biomarkers AFP-L3 and DCP (also known as PIVKA II) have demonstrated their clinical utility in HCC management [7]. Both biomarkers are highly specific for HCC and complement each other [8]. Therefore, when both markers are measured in tandem, the sensitivity is improved while the high specificity is maintained [9,10]. In other words, the combination measurement of three HCC biomarkers will identify a greater number of patients at risk of developing HCC during surveillance than with each marker alone.

Download "HCC Biomarkers Brochure" (pdf)
Download "HCC Biomarkers Bibliography" (pdf)

Learn About HCC Biomarkers
For a slide presentation on how HCC biomarkers can improve surveillance of HCC "HCC Biomarkers for Enhanced HCC Surveillance Feb 2010" (pdf)

AFP-L3 Test - FDA Cleared and CMS Reimbursed

AFP can be fractionated into 3 glycoforms: L1, L2, and L3 based on the reactivity with the lectin Lens culinaris agglutinin (LCA). The AFP-L3 isoform is specific to primary liver cancer. Wako's AFP-L3 test measures the proportion of AFP-L3 isoform to total AFP. AFP-L3% positive (>10%) patients with cirrhosis and chronic Hep B viral infection are highly likely to develop HCC. In addition, AFP-L3 is useful for HCC treatment follow up. AFP-L3 has been reported to be related to tumors with rapid growth, larger size, portal vein invasion and with metastasis [11-13].

Visit "AFP-L3 Test" page for more information.

DCP Test - FDA Cleared and CMS Reimbursed

Wako's DCP (aka PIVKA II) test is the only test that has the FDA clearance for HCC risk assessment in the U.S.

DCP (Des-gamma-carboxy prothrombin), also known as PIVKA-II (proteins induced by vitamin K absence or antagonist-II), is an abnormal form of the coagulation protein, prothrombin. DCP was first discovered as a novel serum marker for HCC in 1984 [14]. Subsequent studies have demonstrated the clinical utility of DCP in HCC detection [15-18]. A 2007 study showed that DCP was highly sensitive (92%) and specific (93%) in differentiating early HCC from cirrhosis [19]. DCP also identified 15 of 17 HCC patients who would have been missed with AFP alone [19].