BURLINGTON, Vt., Sept. 10 BioMosaics Inc., a cancerbiomarker development company, announced today that it has received CE markingfor its proprietary products for the identification of Glypican-3 (GPC3) inhuman blood and in tissue as in vitro diagnostic tests. This will allow theGPC3 (Human Glypican-3) ELISA Kit for detecting GPC3 in human serum or plasma,and the GPC3 (Human Glypican-3) Monoclonal Antibody (clone 1G12) to detectGPC3 in tissue by immunohistochemistry (IHC), to be marketed in the EuropeanUnion.
GPC3, an oncofetal antigen, is a member of the glypican family of glycosylphosphatidylinositol-anchored cell-surface heparan sulfate proteoglycans. Theanti-GPC3 monoclonal antibody (MAb; clone 1G12) has also been used to assessGPC3 expression in malignant and non-malignant liver tissue samples and forELISA detection of GPC3 in the serum. Capurro et al. have shown that GPC3 isexpressed at the protein level by immunohistochemistry in most cases ofprimary liver cancer including small tumors, but is undetectable in normalliver and benign hepatic lesions [Gastroenterology. 2003; 125:89-97]. Threerecent major studies using BioMosaics GPC3 MAb have confirmed the earlypresence of GPC3 on hepatocellular carcinoma (HCC) and highly dysplasticcirrhotic 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 mostcommon and aggressive malignant tumors worldwide, causing an estimated onemillion deaths annually. Over 430,000 new cases of HCC are diagnosed eachyear. 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 past ten years andis expected to continue to rise over the next decade.
"BioMosaics recognizes the importance of developing new diagnostic teststhat could more effectively target a specific type of cancer in the earlystages. We are pleased that we have established these two high qualitydiagnostic products for the EU," said Dr. Ronald D. Guttmann, Executive VPClinical Development.
BioMosaics is a biotechnology company located in Burlington, VT, engagedin the development and commercialization of innovative products for the earlydiagnosis, prediction, and monitoring of cancer.
Note: Statements in this news release that are not historical facts are"forward-looking statements" within the meaning given to that term in thePrivate Securities Litigation Reform Act of 1995. The Company intends thatsuch forward-looking statements be subject to the safe harbors createdthereby. Since these statements involve risks and uncertainties and aresubject to change at any time, the Company's actual results could differmaterially from expected results.Contacts: BioMosaics Inc. http://www.biomosaics.com Mark Allegretta PhD; [email protected]
Ronald D. Guttmann MD; [email protected]
SOURCE BioMosaics Inc.