CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (Nasdaq: CERS) today announced that the FDA has issued
a final guidance document recommending protocols for reducing the risk
of transfusion transmitted Babesiosis. In 15 Babesiosis endemic states,
treating donated blood components with the INTERCEPT Blood System is a
recognized alternative to year-round Babesia testing using a DNA-based
test.
“We are pleased that treating donated blood components with a
pathogen-reduction technology such as INTERCEPT was selected as one of
the two options recognized by the FDA to reduce the risk of transfusion
transmitted Babesiosis,” said Dr. Richard Benjamin, Cerus’ chief medical
officer.
“The inclusion of pathogen reduction technology in the Babesiosis
guidelines reinforces the clinical utility of the INTERCEPT Blood
System,” continued Benjamin. “Our broad spectrum of pathogen reduction
from known and emerging pathogens provides a proactive approach for
reducing the risk of transfusion transmitted infections in platelets and
plasma.”
The FDA Guidance Document recognizes year-round implementation of an
FDA-approved pathogen reduction technology or testing donated blood and
blood components for Babesia with a licensed DNA-based test when
collected in Connecticut, Delaware, Maine, Maryland, Massachusetts,
Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode
Island, Vermont, Virginia, Wisconsin and Washington D.C. A complete copy
of the FDA Guidance Document can be viewed at the following URL.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-reducing-risk-transfusion-transmitted-babesiosis
Babesiosis is caused by a microscopic parasite, Babesia microti,
that infect red blood cells and is transmitted by ticks, particularly in
the Northeast and upper-Midwest regions of the U.S. Many individuals
infected with Babesia are asymptomatic and their blood donations have
been documented to transmit disease. Others may develop flu-like
symptoms such as fever, chills, headache, nausea, or fatigue. It can
also lead to hemolytic anemia lasting from several days to several
months. In severe cases, it can result in death, particularly in certain
high risk populations.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field
of blood transfusion safety. The INTERCEPT Blood System is designed to
reduce the risk of transfusion-transmitted infections by inactivating a
broad range of pathogens such as viruses, bacteria and parasites that
may be present in donated blood. The nucleic acid targeting mechanism of
action of the INTERCEPT treatment is designed to inactivate established
transfusion threats, such as hepatitis B and C, HIV, West Nile virus and
bacteria, as well as emerging pathogens such as chikungunya, malaria and
dengue. Cerus currently markets and sells the INTERCEPT Blood System for
both platelets and plasma in the United States, Europe, the Commonwealth
of Independent States, the Middle East and selected countries in other
regions around the world. The INTERCEPT red blood cell system is in
clinical development. See http://www.cerus.com
for information about Cerus.
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Tim Lee – Investor Relations Director
Cerus Corporation
925-288-6137
Source: Cerus Corporation