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Cerus (NASDAQ:CERS) has received approval from the US Food and Drug Administration (FDA) for use of its Intercept blood system for treatment of platelets suspended in 100 percent plasma.
Cerus (NASDAQ:CERS) has received approval from the US Food and Drug Administration (FDA) for use of its Intercept blood system for treatment of platelets suspended in 100 percent plasma.
As quoted in the press release:
This extended label claim further enhances compatibility with commonly used platelet collection methods.
The INTERCEPT Blood System was initially approved by the FDA in December 2014 for treatment of platelets collected in a commercially available platelet additive solution, InterSol. Use of InterSol is already widespread in Europe; in the U.S., platelet additive solutions have been approved more recently and are still being introduced into blood center and hospital operations.
William ‘Obi’ Greenman, Cerus’ president and chief executive officer, stated:
This additional approval demonstrates further progress toward optimal collection platform compatibility, as we have had in Europe for a number of years. The label claim expansion will be valuable for blood centers as they consider how to address the revised draft guidance document for bacterial safety standards just issued this week by the FDA, as well as the proposed revised standards set forth in the Code of Federal Regulations. A significant number of our customers have been waiting for this approval in order to begin their implementation process for INTERCEPT platelets. We look forward to working with these centers in the coming months to make INTERCEPT platelets more widely available to U.S. hospitals.