Cerus Corp. Applauds the Publication of the Final Guidance Document on Bacterial Safety Standards for Platelet Collection & T...
September 30 2019 - 12:00PM
Business Wire
Cerus Corporation (Nasdaq: CERS) applauds the publication of the
FDA final guidance document titled Bacterial Risk Control
Strategies for Blood Collection Establishments and Transfusion
Services to Enhance the Safety and Availability of Platelets for
Transfusion; Guidance for Industry. The FDA has formally recognized
the risk of transfusion transmitted bacterial infections and the
need for additional safety measures, including the use of
pathogen-reduction technology, to protect patients.
“This is an important day for patients that require platelet
transfusions,” said Dr. Richard Benjamin, Cerus’ chief medical
officer. “It is estimated that approximately one in every 1,500
platelet units contain bacteria despite current testing protocols,
thereby putting these often immunocompromised patients at risk of
sepsis, including the possibility of death. The publication of the
final FDA guidance document and the implementation of its
recommendations will enhance the safety for platelet
transfusions.”
The FDA guidance document published today outlines approaches
that blood centers and hospitals will need to implement over the
next 18 months to reduce the risk of transfusion transmitted
bacterial sepsis. One approach that offers comprehensive protection
against not only bacteria, but also emerging viruses like Zika, is
pathogen reduction. Cerus’ INTERCEPT Blood System is currently the
only FDA approved pathogen-reduction technology to treat platelet
components. The INTERCEPT system uses amotosalen, a well
characterized photochemical compound that specifically binds to DNA
and RNA of bacteria, viruses, and other pathogens, rendering them
inactive. Many of the nation’s largest blood centers and major
academic hospitals, including the American Red Cross, have deployed
the INTERCEPT system in advance of this final FDA guidance
document.
The guidance document can be viewed at the following URL.
https://www.fda.gov/media/123448/download
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the
world’s blood supply and aims to become the preeminent global blood
products company. Based in Concord, California, our employees are
dedicated to deploying and supplying vital technologies and
pathogen-protected blood components for blood centers, hospitals
and ultimately patients who rely on safe blood. With the INTERCEPT
Blood System, we are focused on protecting patients by delivering
the full complement of reliable products and expertise for
transfusion medicine. Cerus develops and markets the INTERCEPT
Blood System, and remains the only company in the blood transfusion
space to earn both CE Mark and FDA approval for pathogen reduction
of both platelet and plasma components. Cerus currently markets and
sells the INTERCEPT Blood System in the United States, Europe, the
Commonwealth of Independent States, the Middle East and selected
countries in other regions around the world. The INTERCEPT Red
Blood Cell system is in clinical development. For more information
about Cerus, visit www.cerus.com.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190930005632/en/
Tim Lee – Investor Relations Director Cerus Corporation
925-288-6137
Cerus (NASDAQ:CERS)
Historical Stock Chart
From Feb 2024 to Mar 2024
Cerus (NASDAQ:CERS)
Historical Stock Chart
From Mar 2023 to Mar 2024