Cerus Corporation (NASDAQ:CERS) announced that the U.S. Food and Drug Administration (FDA) has issued a revised draft guidance document that aims to provide blood centers with sufficient recommendation on how to control the risk of bacterial contamination of platelets. Pathogen reduction technology has been included as a recommended method of reducing the risk of transfusion-transmitted sepsis. The document is titled ‘Bacterial Risk Control Strategies for Blood Collection Establishment and Transfusion Services to Enhance the Safety and Availability of Platelet for Transfusion.

According to the document, the risk of bacterial contamination in platelet unit is higher than in other blood components. The risk is high because of platelet need of being stored at room temperature. Dr. Richard Benjamin, chief medical officer of Cerus , noted that despite screening interventions that were introduced, platelet transfusion is still high at a rate of 1 in 1000. By revising the bacterial standard, the FDA is making a strong statement that there is a need to protect patients from septic transfusion reaction.

The draft recommended that platelet component must either be tested for bacteria or undergo treatment through the pathogen reduction technology. When testing is used to ensure bacterial safety, it must include an early culture test at less than 24 hours after the collection and a subsequent test for any platelet units that are stored for four to five days. When pathogen reduction is used, there is no need for preventive testing.

Intercept Blood System is the currently the only FDA-approved pathogen reduction technology as of now.

Carol Moore, who is Cerus’ senior vice president of regulatory affairs and quality, noted that the inclusion of a pathogen reduction option gives blood centers the chance of eliminating early bacterial culture test, allowing the release of platelet components to hospitals sooner. Also, hospitals avoid changing their operational procedures to include subsequent testing.

Previous articleBaxalta Inc (NYSE:BXLT) Announce Secondary Public Offering of Common Stock
Next articleBroke Out Inc (OTCMKTS:BRKO) inflates further, could OncBioMune Pharmaceuticals (OTCQB:OBMP) be next
Steve Kanaval: Portfolio Manager/Writer/ Market Analyst Steve began his career in the Trading Pits in Chicago making markets at the Chicago Mercantile Exchange (NYSE:CME) the Chicago Board of Trade and the CBOE in the early 80’s. He ran the Morgan Stanley Derivative Prop Trading for the firm specializing in Index Arbitrage. He continued his career as a Trader/Portfolio Manager for multiple Hedge Funds during the Internet Boom of the 90’s managing large portfolios. Steve is known as an expert in MicroCap Technology Stocks and the emerging Digital Currency markets as a Portfolio Manager for his Family Office. Steve has managed portfolio’s in volatile asset classes for 3 decades as a commodity trader, hedge fund manager and digital currency trader and miner. Steve publishes his views on the asset classes in a public forum and has published more than 10,000 articles simplifying these complex and volatile assets for readers. His work is published on multiple sites including Bloomberg,,, CryptoCurrencyNews as a paid contributor. His work includes research, journalism and archived video on important market volatility related to stocks, digital currency and other volatile misunderstood asset classes. He offers a humorous, unique insight and the related back stories and drivers for readers interested in volatility and emerging market assets. Full disclosure Steve is long 25 digital currencies and sits on the board of multiple public companies involved in digital currencies, and owns shares in these companies from time to time.