HCC Biomarkers

AFP-L3 and DCP

HCC Biomarkers News

Latest News

Oct. 27th, 2015
HCC surveillance in an era of biomarkers

Doctor Robert G. Gish, a world renowned hepatologist, speaks about the importance of including biomarkers for HCC risk assessment in liver cancer surveillance programs and proposes his current liver surveillance algorithm as a model. To view the presentation;


News Archive

Dec. 27th, 2014
Mayo Clinic customers can now order both AFP-L3 and DCP using a single Test ID (Order Code).

AFP-L3 and DCP are biomarkers with regulatory clearance for the use in risk assessment of hepatocellular carcinoma (HCC). Research and clinical findings have shown that the use of the two biomarkers in combination can improve the ability to find HCC at an early stage. As such the two biomarkers are regularly ordered together.

Mayo Medical Laboratories created a new Test ID called HCC Risk Panel which consists of the two biomarkers to ease the ordering process. The panel can be ordered using the Test ID, HCCPR.


Other reference laboratories similarly offer the panel as a single test code. Please contact your preferred reference laboratory to obtain their HCC risk assessment panel code. Please note that panel names vary from laboratory to laboratory.


Jan. 27, 2014
Wako Life Sciences, Inc. receives the Northern California Section 2013 AACC Outstanding Contribution to Clinical Chemistry in Science and Technology award for the development of the μTASWako® i30 Immunoanalyzer

Mountain View CA, January 27th, 2013–Dr. Shinji Satomura, President, and Dr. Henry Wada, CSO of Wako Life Sciences, Inc., received an award from the Northern California Section of AACC for the scientific and technology contribution to clinical chemistry achieved by the development of the μTASWako i30 Immunoanalyzer.


Jul. 29, 2013
Wako Diagnostics granted Medical Device Licences from Health Canada for the μTASWako® i30 Immunoanalyzer, and AFP-L3 and DCP Assays for Liver Cancer Risk Assessment

Mountain View CA, July 29th, 2013–Wako Diagnostics, a division of Wako Life Sciences, Inc., was issued three Class III Medical Device Licences by Health Canada on April 23, 2013 to market the μTASWako i30 instrument with serum biomarkers lectin-reactive alpha-fetoprotein (AFP-L3) and des-gamma-carboxy prothrombin (DCP) tests for clinical use in Canada. The AFP-L3 and DCP tests are 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.


Jul. 26, 2013
Study results support the use of biomarkers AFP-L3 and DCP for risk assessment in Surveillance

Researchers from Thomas Jefferson University Hospital, Philadelphia, PA, presented study results in a poster at the 2013 Digestive Diseases Week (DDW) Conference, supporting the use of serum biomarkers AFP, AFP-L3 and DCP for Risk Assessment in Surveillance of Patients at Risk for HCC development.


Apr. 1, 2013
Mayo Clinic's Laboratory is now Offering Wako's DCP test

Mayo Clinic, a worldwide leader in Medical Care, is now offering Wako's DCP test (des-gamma-carboxy prothrombin). Wako's DCP test is a serum biomarker test for the risk assessment of patients with chronic liver disease for development of Hepatocellular carcinoma (HCC). The DCP test is now offered at Mayo Medical Laboratories which is a global reference laboratory that operates within Mayo Clinic's Department of Laboratory Medicine and Pathology. The addition of DCP to their test menu will complement their offering of AFP-L3 as the intended use for both tests is HCC risk assessment.

Starting March 2013, this state of the art laboratory facility will perform the DCP test three times per week. The DCP test can be ordered by using Mayo's test code 61844.

For more information, please visit Mayo's Website

March 1, 2011
Announcing 510(k) Clearance of a New Microfluidic-based IVD Test System, the μTASWakoTM i30 Immunoanalyzer, and AFP-L3 and DCP Assays for Liver Cancer Risk Assessment.


Jan. 2009
Wako's DCP test receives a unique CPT code and CMS reimbusement

The Centers for Medicare & Medicaid Services has released the new Clinical Laboratory Fee Schedule test code and final payment for the testing of DCP (Des-gamma-carboxy prothrombin) also known as PIVKA-II. The new code number, unique to DCP, is CPT 83951. This follows the FDA 510(k) clearance of the DCP test in January 2007. Wako's test is the only FDA-cleared DCP assay. Hepatologists and gastroenterologists use DCP as a risk assessment and rule-out test for hepatocellular carcinoma (HCC)

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Nov. 2007
DCP test is now available at major reference labs!

DCP complements AFP-L3% measurement for HCC risk assessment. Simultaneous measurement of AFP-L3% and DCP has been demonstrated to increase the sensitivity for HCC detection while maintaining high specificity. DCP test is 510(k) FDA cleared.

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Aug. 2007
A new North American multicenter study for clinical utility of AFP-L3% for detection of HCC in patients with chronic hepatitis (CH) C virus-related cirrhosis

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June 2007
Mayo Clinic Study evaluates the diagnostic use of the HCC marker, AFP-L3%


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Press release

Feb. 1, 2007
WakoUSA Reports the 510(k) Clearance of Des-Gamma Carboxyprothrombin (DCP) Test for HCC Risk Assessment


Nov. 15, 2006
Wako Diagnostics Reports the Release of a New CPT Code for AFP-L3%


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Other publications

AFP-L3% on CAP Today

AFP-L3% is highlighted in CAP Today July 06 article, "For tumor markers, hope springs eternal."