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Nanogen and Bio-Rad sign licensing agreement.

Bio-Rad Laboratories, Inc. (Hercules, CA; 510-724-7000) and Nanogen, Inc. (San Diego, CA; 858-410-4605) announced that they have entered into a worldwide, non-exclusive license agreement for the two most common gene mutations for the diagnosis of Hereditary Hemochromatosis, a disorder resulting in excessive iron build-up in tissues and major organs of the body. Under the terms of the agreement, Bio-Rad granted Nanogen a license to the C282Y and H63D mutations of the HFE gene for use on Nanogen's proprietary NanoChip System. Specific financial terms of the license have not been disclosed.

Hereditary Hemochromatosis (iron overload disease) is one of the most common genetic disorders in the world. It is estimated that approximately 32 million people in the United States are carriers of the genetic trait responsible for the disorder. Over time, these iron deposits can cause irreversible organ damage and lead to cirrhosis of the liver, hypothyroidism, cardiomyopathy, diabetes mellitus, arthritis, impotence, and death. Although more than a million Americans are clinically affected by the disorder, very few of those -- only about two percent -- are ever diagnosed due to vague symptoms and a lack of awareness.

"Bio-Rad is very pleased to continue our broad licensing efforts to help expand awareness and testing for this treatable, yet under-diagnosed disease," said John Goetz, Vice President of Bio-Rad's the company's Clinical Diagnostics Group. "The demand for molecular-based tests used to detect genetic disorders continues to increase, and we believe the agreement with Nanogen will help accelerate that trend by providing laboratories a greater variety of licensed hemochromatosis testing options."

"This agreement with Bio-Rad strengthens our patent portfolio in the area of molecular detection and analysis and enables Nanogen to introduce the diagnostic market's first 3 SNP multiplex Analyte Specific Reagent (ASR) during 2002 for the simultaneous detection of the three most common mutations associated with Hereditary Hemochromatosis," said Dr. Randy White, Chief Executive Officer of Nanogen.

"Because many important genetic diseases, such as Hereditary Hemochromatosis or cystic fibrosis, involve complex mutational analyses, we believe our technology platform is ideally suited to the expansion of genetic predisposition testing, which continues to grow due to the increasing amounts of genetic information from the Human Genome Project and other related efforts."

The discovery of the HFE gene in 1996 made DNA testing a valuable tool in the early diagnosis of Hereditary Hemochromatosis. Approximately 94% of the mutations associated with the disease can be detected by using molecular DNA studies. Treatment for both symptomatic and pre-symptomatic patients consists of removing blood from the patient in order to lower the level of iron. Early diagnosis followed by early and regular treatment can prevent iron overload and provide patients with a normal life expectancy.

Bio-Rad Laboratories is a multinational manufacturer and distributor of life science research products and clinical diagnostics. The company is world renowned among hospitals, universities, major research institutions, biotechnology and pharmaceutical firms for its commitment to quality and customer service. It serves more than 70,000 research and industry customers worldwide through a network of more than 30 wholly owned subsidiary offices.

Nanogen's goal is to become the leading provider of molecular diagnostic products. The company is seeking to establish the NanoChip System as the standard platform for the detection of genetic mutations and to develop applications for future clinical use. To date, the company has developed one ASR for the detection of Factor V Leiden, and internally validated five research protocols, four associated with cardiovascular disease and one associated with hereditary hemochromatosis, the most common form of iron overload disease. Nanogen markets its NanoChip

Molecular Biology Workstation to scientists and genomics laboratories. The

NanoChip System is intended for laboratory use only.
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Publication:BIOTECH Patent News
Article Type:Brief Article
Geographic Code:1USA
Date:Jun 1, 2002
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