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BioMosaics, Inc. Announces Products For Detection Of The Glypican-3 Biomarker In Human Tissue And Serum


7/14/2006 1:08:52 PM

BURLINGTON, Vt., July 14 /PRNewswire/ -- BioMosaics Inc., a cancer biomarker development company, announced today that it has launched its proprietary products for the identification of Glypican-3 (GPC3) in human tissues and serum. The products are based on the monoclonal antibody clone 1G12, originally developed in the laboratory of Dr. Jorge Filmus, of Sunnybrook and Women's College Health Sciences Centre and the University of Toronto, Canada. The products include the monoclonal antibody pre-diluted for immunohistochemistry (IHC) and an enzyme-linked immunosorbant assay (ELISA) for detection of GPC3 in serum. The products are sold directly by BioMosaics, and are distributed by Funakoshi Co., Ltd. in Japan and Vitro, S.A. in Europe.

GPC3 is a member of the glypican family of glycosyl phosphatidylinositol-anchored cell-surface heparan sulfate proteoglycans. The 1G12 monoclonal antibody has 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]. In addition, the authors found that GPC3 is significantly elevated in the serum of a large proportion of patients with Primary Liver Cancer.

Primary Liver Cancer, or Hepatocellular Carcinoma (HCC), 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 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. The concern over the increasing significance of liver disease and associated primary liver cancer in the U.S. is reflected in the creation of a new NIH Liver Disease Research Branch charged with the implementation of an Action Plan for Liver Disease Research. It is also apparent by the introduction in the U.S. Congress of the National Hepatitis B Act, H.R. 4550 and S. 3558, which specifically identifies liver cancer as a potentially fatal disease whereby regular monitoring can lead to the early detection at a stage where cure is still possible.

"Because many liver cancer deaths may be prevented with early detection and prompt treatment, BioMosaics recognizes the importance of developing new diagnostic tests that could more effectively target a specific type of cancer in the early stages. Preliminary clinical research studies indicate that detection of GPC3 may provide good sensitivity and specificity as a tumor marker, and may ultimately contribute to fulfilling unmet medical diagnostic needs for a devastating cancer," said Ronald D. Guttmann MD, Executive Vice President of Clinical Development.

About BioMosaics

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.

Contacts: BioMosaics Inc. Mark Allegretta PhD; m.allegretta@biomosaics.com Ronald D. Guttmann MD; r.guttmann@biomosaics.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.

BioMosaics Inc.

CONTACT: Mark Allegretta, PhD, m.allegretta@biomosaics.com, or Ronald D.Guttmann, MD, r.guttmann@biomosaics.com, both of BioMosaics Inc.



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