Assays Help Assess Risk for Development of Hepatocellular Carcinoma

The system uses immunochemical and electrophoretic techniques to achieve rapid, accurate, and sensitive assay results.

Wako Diagnostics (Richmond, VA, USA), a division of Wako Chemicals USA, has received 510(k) clearance from the US Food and Drug Administration (FDA; Silver Springs, MD, USA) to market the µTASWako i30 instrument with alphafetoprotein L3 (AFP-L3) and des-gamma-carboxy prothrombin (DCP) in vitro diagnostic (IVD) tests in the USA. The AFP-L3 and DCP assays will help determine the risk for development of hepatocellular carcinoma (HCC).

A bench top automated instrument, the µTASWako i30, is designed for efficiency and ease of use in a clinical chemistry setting. Up to six analytes may be selected per patient sample with the first result reported in nine minutes.

The uTASWako i30 reports AFP-L3%, total AFP, and DCP values using Wako's reagents. This IVD test system is available to hospital laboratories, reference laboratories, and tertiary care centers.

Peter Panfili PhD, general manager, Wako Diagnostics, said, "We expect that the adoption of these biomarkers into HCC surveillance programs will complement the use of imaging technologies to bring about the desired earlier detection and treatment of liver cancer."

Related Links:
Wako Diagnostics
US Food and Drug Administration