Cerus’ INTERCEPT Blood System Provides Alternative to Year-Round Babesia Testing in Latest FDA Guidance Document
CONCORD, Calif.--(BUSINESS WIRE)--May 14, 2019--
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.
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.
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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CONTACT: Tim Lee – Investor Relations Director
KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA
INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY INFECTIOUS DISEASES MEDICAL DEVICES FDA
SOURCE: Cerus Corporation
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PUB: 05/14/2019 08:30 AM/DISC: 05/14/2019 08:31 AM