Bio-Rad Receives Notification From the FDA That It May Proceed With an Investigational New Drug Study for Its Dengue NS1 Ag Micr
May 10 2010 - 8:00AM
Marketwired
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), 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) and (NYSE: BIO.B) 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 Email Contact
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