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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.
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.
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 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).
For In Vitro Diagnostic Use
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.
For In Vitro Diagnostic 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.
For In Vitro Diagnostic 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.
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.