Terumo BCT's Mirasol Reduces the Virus Causing COVID-19 Below the Limit of Detection in Plasma and Platelets

• ■ A study published today in peer-reviewed Vox Sanguinis shows Terumo BCT's Mirasol Pathogen Reduction Technology (PRT) System effectively reduced the titer of SARS-CoV-2 in both plasma and platelet products to undetectable levels.
• ■ Mirasol is designed to add an extra layer of safety to the blood supply.
• ■ In some parts of the world, where Mirasol is approved for use, the device is used to treat convalescent plasma for COVID-19 patients.¹

LAKEWOOD, CO. USA - April 23, 2020 - Today, Vox Sanguinis, a peer-reviewed medical journal, published results from a Terumo BCT study conducted in collaboration with top researchers at Colorado State University. The study examined how well the Mirasol system treated platelets and plasma against the virus causing COVID-19.
 

The results showed that Mirasol is effective against SARS-CoV-2, the virus causing COVID-19, when high virus levels are present in human plasma and platelets.

Study Results²

In the Terumo BCT study, the measured titer of SARS-CoV-2 was below the limit of detection in tissue culture following treatment with riboflavin and ultraviolet light on the Mirasol system. The mean log reductions in the viral titers were ≥ 3.40 and ≥ 4.53 for the plasma units and platelet units, respectively.

Mirasol effectively reduced the titer of SARS-CoV-2 in both plasma and platelets to undetectable levels. The data suggest that the process would be effective in reducing the theoretical risk of transfusion-transmitted SARS-CoV-2.

Changing World = Emerging Pathogens

Pathogen reduction with Mirasol is a method to address emerging and evolving pathogens as the rate of epidemics increases, people travel more and the global climate warms.

"Mirasol adds a layer of safety to blood products by reducing the risk of transfusion transmission of both known and emerging pathogens," says Shawn D. Keil, Scientific Affairs, Terumo BCT, and lead author of the publication. "SARS-CoV-2 won't be the last novel virus to emerge. Using the Mirasol PRT system is a proactive approach to protecting the foundation of healthcare, blood."
 

Dr. Louis Katz, MD, Chief Medical Officer, Mississippi Valley Regional Blood Center, Davenport, Iowa, U.S.A., said: "Once more, in the aftermath of HIV and HCV [the hepatitis C virus], we are reminded that a proactive intervention like pathogen reduction could be of value in urgent and emergent circumstances like the current pandemic."

Pathogen Reduction and Convalescent Plasma

People who have recovered from COVID-19 have antibodies to the disease in their blood. Some healthcare providers are using convalescent plasma for patients with severe COVID-19 to boost their ability to fight the virus.³ Others are considering using convalescent plasma to provide passive immunity to healthcare workers, such as doctors and nurses who have been exposed to the virus but are not showing symptoms. Mirasol may add an extra layer of safety to convalescent plasma, even though there is no evidence that SARS-CoV-2 can be transmitted through transfusion.
 

"The proactive value of pathogen reduction providing blood safety in the event of unknown pathogen outbreaks is shown in this awful COVID-19 pandemic. The riboflavin technology inactivates the SARS-CoV-2, the causative agent of COVID-19, so it should be especially helpful in the treatment of COVID-19 convalescent plasma and to provide additional safety for standard blood products," Dr. Jeffrey McCullough, MD, Professor Emeritus, University of Minnesota Medical School.*

About Mirasol

Using riboflavin (vitamin B2) and ultraviolet light, Mirasol is designed to reduce the pathogen load of various disease-causing agents such as viruses, parasites and bacteria in blood products before they are transfused to patients. Mirasol also inactivates white blood cells to help reduce certain transfusion reactions.
 

Mirasol is CE marked for platelets, plasma and whole blood and is in routine use in more than 20 countries throughout Europe, the Middle East, Africa, Asia and Latin America. The system is not approved for sale in the U.S. and Canada.
 

There are no approved devices or therapies for specific treatment of COVID-19.
 

www.terumobct.com/mirasol
 

¹Study funded by Terumo BCT and conducted at Colorado State University, Fort Collins, Colo.
Authors: From Terumo BCT: Shawn D. Keil, Susan Yonemura and Nicole K. Dart. From CSU's Department of Biomedical Sciences, Fort Collins, Colo.: Izabela Ragan and Richard Bowen. From CSU's Infectious Disease Research Center, Fort Collins, Colo.: Lindsay Hartson.

²Read the full article, Inactivation of severe acute respiratory syndrome coronavirus 2 in plasma and platelet products using a riboflavin and ultraviolet light-based photochemical treatment, here.
 

³The International Society for Blood Transfusion (ISBT) Global Blood Safety Working Party recommends, where feasible, pathogen inactivation of plasma to control residual risks of transfusion-transmitted infectious diseases and to alleviate concern about possible superinfections with SARS-CoV-2, the virus that causes COVID-19.Jay Epstein and Thierry Burnouf, on behalf of the ISBT Working Party on Global Blood Safety. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Details here: https://isbtweb.org/fileadmin/user_upload/Points_to_consider_in_the_preparation_of_COVID_convalescent_plasma_-_200331_ISBT_WP_GBS_Final.pdf.

*Dr. McCullough serves as an advisor to Terumo BCT and is the Principal Investigator on a clinical trial that involves the use of Mirasol in the treatment of platelets for transfusion.

About Terumo BCT

Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular therapy technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction technologies. We believe in the potential of blood and cells to do even more for patients than they do today. This belief inspires our innovation and strengthens our collaboration with customers. TERUMOBCT.com

Global Terumo BCT Mirasol Support

[email protected]

About Colorado State University

Founded in 1870 as the Colorado Agricultural College, Colorado State University is now among the nation's leading research universities, with annual research expenditures of nearly $400 million. The CSU System includes the flagship campus in Fort Collins as well as CSU-Pueblo and CSU-Global. In Fort Collins, CSU currently enrolls about 33,000 students, including 4,000 graduate students and 580 in the Doctor of Veterinary Medicine program, and has more than 1,800 faculty members working in eight colleges. CSU's DVM program consistently ranks among the top three veterinary medicine programs in the nation.

About the Infectious Disease Research Center at Colorado State University

Colorado State University's Infectious Disease Research Center provides a high-quality research environment for developing new scientific discoveries, vaccines, methods of diagnosis and therapeutic agents for infectious agents. CSU is among the world's leaders in researching West Nile virus, drug-resistant tuberculosis, yellow fever, dengue, hantavirus, plague, tularemia and other diseases. The IDRC contains the Bio-pharmaceutical Manufacturing & Academic Resource Center (BioMARC) which is a fully functional BSL3 GMP facility that works across government, foundations, industry and academic partners to scale innovations in infectious disease. In addition, the IDRC contains a national node in the biocontainment regional laboratory network, with over 50,000 square feet of BSL3 research space for projects executed at CSU and in partnership with many others.