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 past ten years and is expected to continue to rise over the next decade.
"BioMosaics recognizes the importance of developing new diagnostic tests that could more effectively target a specific type of cancer in the early stages. We are pleased that we have established these two high quality diagnostic products for the EU," said Dr. Ronald D. Guttmann, Executive VP Clinical Development.
BioMosaics is a biotechnology company located in Burlington, VT, engaged in the development and commercialization of innovative products for the early diagnosis, prediction, and monitoring of cancer.
Mark Allegretta PhD; firstname.lastname@example.org
Ronald D. Guttmann MD; email@example.com
Note: Statements in this news release that are not historical facts are "forward-looking statements" within the meaning given to that term in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Company's actual results could differ materially from expected results.
CONTACT: Mark Allegretta, PhD, firstname.lastname@example.org, or Ronald D.Guttmann MD, email@example.com, both of BioMosaics Inc.,+1-802-656-5443