BioMosaics' Glypican-3 Antibody (clone 1G12) Validated at PhenoPath Laboratories for Immunohistochemical Detection of Li... ( BURLINGTON Vt. and SEATTLE March 26 /...)

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BioMosaics' Glypican-3 Antibody (clone 1G12) Validated at PhenoPath Laboratories for Immunohistochemical Detection of Liver Cancer

Date:3/26/2009

BURLINGTON, Vt. and SEATTLE, March 26 /PRNewswire/ -- 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.

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