Cerus (CERS) Affirms Revised FDA Guidance with Respect to Zika Virus Testing
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Cerus Corporation (Nasdaq: CERS) announced that the U.S. Food and Drug Administration (FDA) has issued a revised guidance document, titled "Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components," which extends its recommendation of appropriate blood safety measures to apply to all U.S. blood centers. Use of pathogen reduction, such as the INTERCEPT Blood System for platelets and plasma, is specified as an acceptable safety measure.
In contrast to the original Zika guidance issued in February, the revised guidance now recommends that Zika risk reduction measures be implemented even outside of areas with active local transmissions (currently Florida and Puerto Rico). For the 11 states considered proximate to the current areas of local transmission or at increased risk for local mosquito-borne cases due to other Zika risk factors (Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina, and Texas), implementation is required within 4 weeks. All other states have 12 weeks to comply with the revised guidance.
The revised guidance gives U.S. blood centers the choice to either test blood donations with an investigational individual donor nucleic acid test, or implement pathogen reduction technology for platelets or plasma using an FDA-approved pathogen reduction device. The INTERCEPT Blood System for platelets and plasma was approved by the FDA in December 2014, and is already in use by 15 blood centers nationwide, including the American Red Cross. An additional 15 blood centers are under contract, with implementation in progress. A list of INTERCEPT customers in the U.S. is available online at http://intercept-usa.com/implement-intercept/us-customer-list.
“Recent publications have demonstrated likely cases of Zika virus transmission through blood transfusion in Brazil,” said Carol Moore, Cerus’ senior vice president of regulatory affairs and quality. “With cases of mosquito-borne Zika infections increasing in Florida and the potential for infections to expand into other at-risk states, the FDA's revised guidance demonstrates an increasing level of concern about the threat of transfusion transmission in the U.S. Cerus stands ready to assist blood centers in complying with the FDA's new recommendations.”
Pathogen reduction treatment of blood components offers the opportunity for proactive protection against epidemic and endemic pathogens such as Zika, dengue, and chikungunya that may be present in donated blood. Pathogen reduction has also been identified as a measure for reducing the risk of bacterial contamination of platelets to prevent against transfusion-transmitted sepsis.
For the complete FDA guidance document, please visit http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM518213.pdf
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