Cerus Corporation (Nasdaq: CERS) announced today the publication of a new recommendation from the German National Blood Advisory Committee (Arbeitskreis Blut or AK Blut), which recommends proactive measures, including pathogen inactivation (PI) such as INTERCEPT, as core measures to enhance the safety of platelet transfusions. AK Blut is an expert committee that advises the German federal authorities on the safety of blood, blood products, and cells for transfusion.
"We believe today's recommendation from AK Blut affirms the critical role of pathogen inactivation in protecting patients from transfusion-transmitted bacterial infections. Enhancing patient safety is clearly a key priority of AK Blut and blood centers around the world and the INTERCEPT Blood System has an extensive track record of over 20 million blood components treated globally," said Christian Boutemy, Cerus' vice president of international commercial operations. "Over 600,000 platelet doses are produced annually in Germany, more than any other European country, and we look forward to collaborating with German blood banks and hospitals to enhance the safety and reliability of the platelet supply. INTERCEPT Blood System for Platelets is approved and commercially available in Germany."
The report, Enhancing the Bacteriological Safety of Platelet Concentrates, highlights that while existing safeguards have reduced the risk of transfusion-transmitted bacterial infections (TTBI), a significant residual threat remains. Passive surveillance data suggests about 5 clinical cases of TTBI per million platelet transfusions, but active screening studies suggest that up to 1,300 units of platelet components per million are contaminated.
Pathogen inactivation, such as with Cerus' INTERCEPT Blood System for Platelets, directly addresses this challenge by proactively reducing a broad range of bacteria, viruses, and parasites within platelet units. Unlike sample-based testing methods, AK Blut states that PI eliminates the risk of false negatives, and is already widely adopted in countries such as France, Belgium, and Switzerland, where it has significantly reduced transfusion-related sepsis.
According to the recommendation, the AK Blut concludes that:
- Platelet units should be treated with pathogen inactivation or a validated bacterial screening test.
- PI-treated platelets be considered microbiologically safe for up to seven days following collection, with the functionality checked over the storage period.
- Untreated platelets, without bacterial testing, can be transfused for up to three days (compared to the current shelf life of four days).
- Adjusting reimbursement rates for PI-treated platelets to cover blood center costs related to treating platelets with pathogen inactivation.
The position paper can be found at www.rki.de/DE/Themen/Infektionskrankheiten/Blut-und-Transfusionsmedizin/Arbeitskreis-Blut/Stellungnahmen/Downloads/S29.pdf?__blob=publicationFile&v=2.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the world's blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. In the U.S., the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the U.S. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
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Contacts:
Tim Lee Head of Investor Relations
Cerus Corporation
ir@cerus.com
925-288-6128
