The US FDA has approved Wako Diagnostics’s new LBA AFP-L3 test system. It is intended for the risk assessment of developing hepatocellular carcinoma (HCC), liver cancer in patients with chronic liver diseases (CLD).

Hepatocellular carcinoma (HCC) is the 4th most common cancer in the world and the 3rd most common cause of cancer-related death. In the US, the incidence of HCC has increased approximately 80% over the past 20-30 years, and there are approximately 18,000 new cases annually. Chronic hepatitis (CH) caused by the hepatitis B or C virus (HBV, HCV) and liver cirrhosis (LC) are established significant risk factors for the development of HCC.

A multi-centre, prospective, double-blinded, longitudinal, clinical study was carried out in the US and Canada to determine the clinical utility of AFP-L3% as a risk assessment marker of HCC. Patients with elevated AFP-L3% (10% or more) have been shown to be associated with a 7-fold increase in the risk of developing HCC within the next 21 months. These patients should be more intensively evaluated for evidence of HCC, according to the existing HCC practice guidelines in oncology.

The presence of serum AFP in patients with hepatocellular carcinoma and yolk sac tumour was demonstrated in the 1960s. It is now clinically accepted that increases in serum AFP occur in patients with chronic hepatitis (CH) and liver cirrhosis (LC), even in the absence of HCC. It is difficult to distinguish between HCC and such benign diseases using AFP. Unfortunately, AFP is neither sensitive nor specific for HCC. A more specific test is needed. Wako's AFP-L3% test was developed to help fill this medical need, a company release stated.