Cerus’ INTERCEPT Blood System Provides Alternative to Year-Round Babesia Testing in Latest FDA Guidance Document
May 14 2019 - 8:44AM
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 DirectorCerus
Corporation925-288-6137
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