Cerus Corporation Applauds FDA Requirements Effective Today to Safeguard the U.S. Platelet Supply

Rhea-AI Summary

Today, the FDA's final guidance on bacterial risk control for platelet collection and transfusion takes effect, promoting the INTERCEPT Blood System for platelets by Cerus (CERS) as a compliant pathogen reduction solution. This system not only addresses bacterial contamination—recognized as a major risk in the U.S.—but also inactivates a range of viruses and parasites. The guidance aims to enhance platelet safety and availability for transfusions across the U.S., marking a significant milestone in transfusion medicine, as INTERCEPT is currently the only FDA-approved measure for compliance.

Positive

• Cerus' INTERCEPT Blood System for platelets is now the only FDA-approved pathogen reduction method in the U.S., enhancing safety for transfusions.
• The FDA guidance is expected to help solidify Cerus' position in the market as a leader in blood safety technology.
• INTERCEPT system reduces risks beyond bacterial contamination, including viruses and parasites, potentially leading to broader adoption.

Negative

• None.

CONCORD, Calif.--(BUSINESS WIRE)-- Today marks the effective date for the U.S. Food and Drug Administration’s (FDA) final guidance document on bacterial risk control strategies for platelet collection and transfusion. This guidance for industry, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelet for Transfusion,” which was finalized in 2020, identifies FDA-approved pathogen reduction as a means of compliance and, as such, provides a way to protect the U.S. platelet supply from bacterial contamination using the INTERCEPT Blood System for platelets. Cerus Corporation’s (Nasdaq: CERS) INTERCEPT Blood System for platelets also reduces risk beyond bacteria, inactivating a broad range of viruses and parasites, as well as the white blood cells that can cause transfusion-associated graft-versus-host disease.

“The steps called for by the FDA guidance mark a significant milestone for the field of transfusion medicine, the safety of platelet transfusions, and the health of patients across the country,” said Dr. Laurence Corash, Cerus’ chief scientific officer and co-founder. “Bacterial contamination in platelets has been recognized as the greatest transfusion-transmission infectious risk in the United States.¹ Transfusing a contaminated unit can cause numerous issues for transfusion recipients, including transfusion-transmitted infection that can lead to severe adverse outcomes for these patients.”

“As blood centers and their hospital customers have been working tirelessly to choose and deploy measures that will ensure compliance with the new FDA guidance, we have been working alongside these customers with the goal of making the INTERCEPT Blood System for platelets the standard of care in the U.S. market. I am pleased that patients across the U.S. will have an additional layer of safety, enabled by our platform,” continued Corash.

For two decades, the INTERCEPT Blood System for platelets and plasma has been used around the world to help safeguard the supply of platelets and plasma. Today, Cerus’ INTERCEPT Blood System for platelets is the only FDA-approved pathogen reduction measure currently available in the U.S. for compliance with the FDA guidance.

1. Centers for Disease Control and Prevention: https://www.cdc.gov/bloodsafety/bbp/bacterial-contamination-of-platelets.html

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. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of INTERCEPT Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211001005138/en/

Matt Notarianni – Senior Director, Investor Relations

Cerus Corporation

925-288-6137

Source: Cerus Corporation

FAQ

What is the significance of the FDA's final guidance on bacterial risk control for platelets?

The final guidance promotes the use of pathogen reduction measures, specifically the INTERCEPT Blood System by Cerus, to enhance the safety of platelet transfusions in the U.S.

How does the INTERCEPT Blood System for platelets work?

The INTERCEPT Blood System inactivates pathogens such as bacteria, viruses, and parasites, ensuring safer platelet transfusions.

What are the implications of the FDA guidance for Cerus Corporation (CERS)?

The FDA guidance positions Cerus' INTERCEPT Blood System as the standard for compliance, potentially boosting its market share and financial performance.

When did the FDA's guidance on bacterial risk control take effect?

The FDA's final guidance on bacterial risk control for platelet collection and transfusion became effective today.

Is the INTERCEPT system used globally?

Yes, the INTERCEPT Blood System for platelets and plasma is used worldwide and is the only system with both CE mark and FDA approval.