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Team Project

Liver Full Reference Set Application: Hiro Yamada - Wako (2011)

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Yamada, HiroWako Diagnostics
Feng, ZidingFred Hutchinson Cancer Research Center
AFP, AFP-L3 and DCP
Proteomics
G.I. and Other Associated Cancers Research Group

Wako has received new 510(k) clearance for Lens culinaris agglutinin-reactive fraction of alpha-fetoprotein (AFP-L3) and Des-gamma-carboxy prothrombin (DCP) tests on an innovative μTASWako i30 analyzer from FDA. The AFP-L3 and DCP assayed on an older platform LiBASys have been cleared with indication of use for risk assessment of hepatocellular carcinoma (HCC) in patient at risk for the liver malignancy. Wako believes that early detection of HCC is critical for improving HCC patient outcome. Therefore, Wako is currently seeking collaborative opportunities to retrospectively measure clinical samples using the AFP-L3 and DCP for further determining of effectiveness of the HCC biomarkers in early detection which are collected prospectively during HCC surveillance. The Reference Sample Set in the EDRN biorepository are well characterized and studied. Access to these samples would allow Wako to quickly determine the clinical effectiveness of AFP-L3 and DCP in detecting early HCC

The specific aim of the proposal is to determine usefulness of the HCC biomarkers in early detection.
Sensitivity and specificity of AFP, AFP-L3 and DCP assays on the μTASWako i30 will be calculated for the patients using several cutoff values (5%, 7%, 10% etc). Sensitivity by tumor characteristics (stage, size and number) will be evaluated, if the clinical information on the patient characteristics is available.

No datasets are currently associated with this protocol.


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