BioMosaics Inc, a cancer biomarker development company, announced today that its 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) by PhenoPath Laboratories.
PhenoPath Laboratories is a state-of-the-art reference pathology laboratory providing diagnostic immunohistochemistry (IHC), in situ hybridization (ISH), flow cytometry, and other molecular pathology services to pathologists throughout the United States.
"We are pleased that PhenoPath has added the 1G12 Glypican-3 antibody to its test menu. Immunohistochemistry using this antibody provides added specificity to the identification of HCC in patient tissue samples," said Dr Mark Allegretta, BioMosaics Chief Scientific Officer. PhenoPath is CLIA-certified and accredited by the College of American Pathologists. In addition to testing performed at PhenoPath, the antibody is available in concentrated form (BioMosaics Catalog # B0055 and B0025), or as a ready-to-use, pre-diluted product for IHC (Catalog # B0134). Both formats are suitable for use with manual protocols or in automated immunostaining instruments.
The antibody validation studies were performed with formalin fixed paraffin embedded tissue sections used in routine immunohistochemistry tests. For validation, a series of tissues (normal & 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 GPC3, 88% (38/43) of cases with hepatocellular carcinoma showed strong positive immunostaining. In all observed cases, non-neoplastic 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.
Primary Liver Cancer, or 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.
Glypican-3, an oncofetal antigen, is a member of the glypican family of GPI-anchored cell-surface heparan sulfate proteoglycans. Many studies have shown that, using the 1G12 antibody, GPC3 is detected at the protein level by immunohistochemistry in most cases of primary liver cancer, including small tumors. It is undetectable in normal liver and benign hepatic lesions.
Glypican-3 has been identified as one of the earliest proteins detected in HCC. Recent validation studies using BioMosaics GPC3 1G12 monoclonal antibody have confirmed the early presence of GPC3 on HCC biopsies and in a percentage of highly dysplastic cirrhotic nodules. This class of dysplastic nodule is considered to be an early form of HCC, and immunohistochemical studies show that they are routinely negative for alpha fetoprotein.
Glypican-3 therefore has considerable promise as a biomarker for early detection of HCC.
Source: BioMosaics Inc