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BioMosaics' Glypican-3 Blood & Tissue Tests Receive CE Marking in Europe
Date:9/10/2007

BURLINGTON, Vt., Sept. 10 /PRNewswire/ -- BioMosaics Inc., a cancer biomarker development company, announced today that it has received CE marking for its proprietary products for the identification of Glypican-3 (GPC3) in human blood and in tissue as in vitro diagnostic tests. This will allow the GPC3 (Human Glypican-3) ELISA Kit for detecting GPC3 in human serum or plasma, and the GPC3 (Human Glypican-3) Monoclonal Antibody (clone 1G12) to detect GPC3 in tissue by immunohistochemistry (IHC), to be marketed in the European Union.

GPC3, an oncofetal antigen, is a member of the glypican family of glycosyl phosphatidylinositol-anchored cell-surface heparan sulfate proteoglycans. The anti-GPC3 monoclonal antibody (MAb; clone 1G12) has also been used to assess GPC3 expression in malignant and non-malignant liver tissue samples and for ELISA detection of GPC3 in the serum. Capurro et al. have shown that GPC3 is expressed at the protein level by immunohistochemistry in most cases of primary liver cancer including small tumors, but is undetectable in normal liver and benign hepatic lesions [Gastroenterology. 2003; 125:89-97]. Three recent major studies using BioMosaics GPC3 MAb have confirmed the early presence of GPC3 on hepatocellular carcinoma (HCC) and highly dysplastic cirrhotic nodules. [Wang XY et al, Human Pathology. 2006; 37(11):1435-41, Libbrecht et al, Am J Surg Pathol. 2006. 30(11):1405-1411, and Di Tommaso, Hepatology. 2007; 45(3):725-34].

Primary Liver Cancer, or Hepatocellular Carcinoma, is one of the most common and aggressive malignant tumors worldwide, causing an estimated one million deaths annually. Over 430,000 new cases of HCC are diagnosed each year. 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, diabetes, and insulin resistance factors. The incidence of HCC has been steadily increasing over the
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