Immunohistochemical Test Validated for Diagnosis of Hepatocellular Carcinoma

A monoclonal antibody product (clone 1G12) for detection of Glypican-3 (GPC3) has been validated for use as an immunohistochemical test for diagnosis of Hepatocellular Carcinoma (HCC).

The antibody validation studies were performed at PhenoPath Laboratories (Seattle, WA, USA) with formalin fixed paraffin embedded (FFPE) tissue sections used in routine immunohistochemistry tests. A series of tissues (normal and tumor) that would be part of the differential diagnosis in a clinical setting were tested to determine what percent might be positive. With the 1G12 antibody to GPC 3, 88% (38/43) of cases with hepatocellular carcinoma showed strong positive immunostaining. In all observed cases, nonneoplastic liver that was present in the specimen was negative or showed rare cells positive for Glypican-3. All 21 cases of nodules in cirrhotic liver were negative for Glypican-3.


The monoclonal antibody (clone 1G12) was produced by of BioMosaics (Burlington, VT, USA), a biotechnology company engaged in the development and commercialization of products for the early diagnosis, prediction, and monitoring of cancer. The antibody is available in concentrated form or as a ready-to-use, pre-diluted product for IHC. Both formats are suitable for use with manual protocols or in automated immunostaining instruments.

Hepatocellular Carcinoma, is one of the most common and aggressive malignant tumors worldwide, causing an estimated one million deaths annually. The main causative agents are hepatitis B virus (HBV), hepatitis C virus (HCV), as well as alcoholic cirrhosis and non-alcoholic steatohepatitis (NASH), which is associated with obesity and diabetes. The incidence of HCC has been steadily increasing over the past ten years and is expected to continue to rise over the next decade.

PhenoPath Laboratories is a reference pathology laboratory providing diagnostic immunohistochemistry (IHC), in situ hybridization (ISH), flow cytometry, and other molecular pathology services to pathologists throughout the United States.

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PhenoPath Laboratories
BioMosaics