Pathogen Reduction: What’s Changed in the Last Two Years?
When I last commented on pathogen reduction (PR) in an "Our Space" two years ago, there was a sense of hope that PR was at our doorstep. Cerus had just received the greenlight from FDA to submit Premarket Approval applications for its Intercept system for platelets and for plasma, which gained licensure in 2014. Now, Terumo BCT has submitted an Investigational Device Exemption (IDE) to begin its MiPLATE study for the Mirasol PRT system for platelets, which is expected to lead to licensure of the system. Terumo BCT is also developing a PR platform for whole blood. Data from the company's IMPROVE II feasibility study, focused on radiolabel recovery of red blood cells after 21 day storage from PR-treated whole blood, has been submitted as an abstract for the 2015 AABB meeting in Anaheim, Calif.
During this time, the relentless onward march of new and emerging infectious agents continued. To name a few, the world's health agencies and local healthcare workers faced the 2014 Ebola epidemic, and Chikungunya and Dengue viruses continue growing in the Caribbean and other global hot spots. Most recently, the blood community and FDA are considering possible blood donor screening for Babesia, including both regional and temporal screening scenarios. Malaria and malaria travel deferrals continue to hinder not only world health, but our ability to collect blood.
In the related matter of bacterial contamination of platelets, the FDA draft guidance in December 2014 presented overly complex options for culturing and point-of-release assays in both blood centers and hospitals. Surprisingly, FDA made no mention of the most effective intervention, PR, despite the very relevant and imminent approval of the first PR system for platelets. With our input to FDA, hopefully the final guidance will include pathogen reduction in lieu of some or all of the described testing schemes. Current AABB Standards already require that we detect "or inactivate" bacteria in platelets.
Like others in our industry, I hope to assimilate PR into blood manufacturing because I want to pursue proactive, rather than reactive, strategies against emerging infectious agents that may threaten transfusion safety. I also believe that PR will help us avert costs and unnecessary work, rather than be cost prohibitive. A number of US blood centers have already contracted with Cerus to produce Intercept-treated platelets, and are submitting biologics license applications (BLAs) to distribute these products across state lines without bacterial culturing. They also intend to eliminate cytomegalovirus (CMV) testing and irradiation in these platelets.
I applaud this progress and I look forward to joining the party.
Chris Staub, MT(ASCP) SBB, Board Member; email@example.com