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Bio-Rad Laboratories, Inc. (BIO) Receives Notification From the FDA That It May Proceed With an Investigational New Drug Study for Its Dengue NS1 Ag Microplate Assay


5/10/2010 6:41:28 AM

HERCULES, CA and WASHINGTON, DC--(Marketwire - 05/10/10) - Bio-Rad Laboratories, Inc. (NYSE:BIO - News) and (NYSE:BIO.B - News), a multinational manufacturer and distributor of life science research and clinical diagnostic products, and the American Red Cross, today announced that the U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, has notified Bio-Rad that it may proceed with its Investigational New Drug (IND) study for the Bio-Rad Dengue NS1 Ag microplate assay. The Red Cross will use the immunoassay to screen approximately 80,000 blood donations from Puerto Rico, where dengue currently is endemic.

The Dengue NS1 Ag test is an easy-to-perform assay for detection of dengue NS1 antigen in serum or plasma. Bio-Rad introduced the Dengue NS1 Ag test in 2006 as the first and only available dengue antigen detection test on the market. The test is currently used in over 40 countries throughout the world. Results of the IND study may open the doors for Bio-Rad to introduce the Dengue NS1 Ag test to U.S. markets.

"Transfusion-transmitted dengue infections are a potential threat for blood recipients in Puerto Rico," said John Goetz, Bio-Rad Vice President and Group Manager Clinical Diagnostics. "Detection of the dengue NS1 antigen in patients' sera has proven to be a superior method for early diagnosis of a dengue infection."

About Dengue Fever

Dengue is an endemic disease affecting people in tropical and subtropical regions around the world and is considered the most important arboviral disease in terms of morbidity, mortality, and socio-economical costs. Dengue is transmitted by mosquitoes and no vaccine is currently available. The dengue NS1 antigen, detected by Bio-Rad's Dengue NS1 Ag microplate assay, identifies the presence of the dengue virus in the patient's blood. Since its introduction in 2006, numerous independent and international studies on the test have been published.

Dengue is currently endemic in more than 100 countries and has the potential to affect 40% of the earth's population. The World Health Organization estimates that there are about 50 to 100 million cases of dengue infections worldwide every year that result in 250,000 to 500,000 severely complicated forms of the disease and 24,000 deaths each year. The most affected regions are Southeast Asia, the Indian subcontinent, Latin America, and South America. Anyone travelling to these areas may contract the disease.

About Bio-Rad

Bio-Rad Laboratories, Inc. (NYSE:BIO - News) and (NYSE:BIO.B - News) has remained at the center of scientific discovery for more than 50 years, manufacturing and distributing a broad range of products for the life science research and clinical diagnostics markets. The company is renowned worldwide among hospitals, universities, major research institutions, as well as biotechnology and pharmaceutical companies for its commitment to quality and customer service. Founded in 1952, Bio-Rad is headquartered in Hercules, California, and serves more than 85,000 research and industry customers worldwide through its global network of operations. The company employs over 6,800 people globally and had revenues of nearly $1.8 billion in 2009. For more information, please visit www.bio-rad.com.

About the American Red Cross

The American Red Cross shelters, feeds, and provides emotional support to victims of disasters; supplies nearly half the nation's blood; teaches lifesaving skills; provides international humanitarian aid; and supports military members and their families. The Red Cross is a charitable organization -- not a government agency -- and depends on volunteers and the generosity of the American Public to perform its mission. For more information, please visit www.redcross.org or join our blog at http://blog.redcross.org.

For More information, contact: Bio-Rad Laboratories, Inc. Tina Cuccia, Corporate Communications 510-724-7000 Email Contact American Red Cross Stephanie Millian, Biomedical Communications 202-303-4488


Read at BioSpace.com


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