µTASWako i30 market launch
µTASWakoTM i30 – Market launch: CE-marking and U.S. FDA clearance completed
Wako Chemicals GmbH now offers the biomarker tests AFP-L3% and DCP for Hepatocellular Carcinoma (HCC) using the new µTASWakoTM i30 instrument as CE-marked in vitro diagnostic products.
After the completion of the CE-marking process and the 510(k) clearance by the U.S. FDA the tests for AFP-L3% and DCP using microfluidic chip technology are now available outside of Japan. Recent clinical publications have shown that the combined measurement of both markers using the new technology improves the specific detection of HCC at early stages in AFP negative patients. In combination with imaging technologies these biomarkers could improve the early recognition of HCC prerequisite for the initiation of curative treatments.
The µTASWakoTM i30 instrument measures the HCC biomarkers in a fully automated, highly sensitive and precise procedure. The bench top analyzer has advanced features and enables fast and flexible measurements in clinical laboratories.
For detailed information please click here for die HCC biomarker page.