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American Red Cross Accelerates Conversion to PLAS+RSD.

WASHINGTON, D.C.--(BUSINESS WIRE)--Sept. 30, 1999--

Over the next year, the American Red Cross will implement a plan to accelerate to a full conversion of fresh frozen plasma to its virus-inactivated alternative, PLAS+(R)SD (Pooled Plasma, Solvent Detergent Treated).

Consistent with this conversion policy, the American Red Cross will offer more favorable pricing initiatives to make Plas+SD available to more patients nationwide and to reduce the burden to hospital budgets. Additionally, the American Red Cross has just signed an agreement with Novation, the nation's largest group purchasing organization, to facilitate the distribution of Plas+SD to approximately 2,000 hospitals. Under the Novation agreement, member hospitals will be able to obtain favorable prices for Plas+SD.

"The American Red Cross believes that virus inactivation is an appropriate mechanism to help safeguard the blood supply," said Jacquelyn Fredrick, chief operating officer of the American Red Cross Blood Services. "We are continually exploring new methods of virus inactivation; Plas+SD represents the first time a technology to inactivate viruses has been successfully applied to a blood component."

According to Dr. Richard Davey, chief medical officer of the American Red Cross, "The American Red Cross believes that virus inactivation will become the standard of care for all blood components. Plas+SD has the advantage of destroying any lipid-enveloped viruses that may be present in collected blood by stripping away their lipid (fatty) coating. We look forward to new generations of virus inactivated blood products as they become available."

In the April 1999 issue of Transfusion Medicine Reviews, Celso Bianco, MD, vice president of the New York Blood Center, identified Plas+SD as an excellent choice for the following conditions: treatment of TTP (a potentially life-threatening blood platelet disorder), coagulation factor deficiencies where a specific concentrate is not available, treatment of severe liver disease, and reversal of warfarin (anticoagulant) therapy. "We concur with these recommendations," added Dr. Davey.

Plas+SD is a solvent detergent treated, pooled frozen plasma product for transfusion manufactured for the American Red Cross by V. I. Technologies, Inc. (VITEX). Introduced in May 1998, Plas+SD is an alternative to other forms of fresh frozen plasma available in the U.S. The proven solvent detergent (SD) process inactivates lipid-enveloped viruses, such as those that cause AIDS, hepatitis B and hepatitis C. Plas+SD is also sterile filtered, resulting in a leukoreduced product free of the largest von Willebrand Factor multimers, bacteria and parasites.

Non lipid-enveloped viruses such as hepatitis A and parvovirus B19 are not affected by the SD process. However, all lots of Plas+SD are PCR tested as negative for HAV nucleic acid prior to release.(a) Alternative products, including fresh frozen plasma and donor retested plasma, are neither virus inactivated nor routinely tested for hepatitis A virus. On July 23, 1999, VITEX submitted a validation protocol to the Food and Drug Administration for a similar PCR test for parvovirus B19.

The blood supply today is safer than it has ever been, and the Red Cross is constantly working to make it even safer. Improved donor screening techniques, infectious disease testing, introduction of nucleic acid testing for HIV and hepatitis C virus, and virus inactivation procedures have greatly enhanced the safety of blood components and products in the United States. These enhancements are consistent with the Red Cross mission to provide the safest possible blood supply for the American people.

The American Red Cross is the nation's largest supplier of blood, plasma and tissue products in the United States. The Red Cross supplies almost half of the nation's blood supply by working with more than 4.5 million donors and 3,000 hospitals through its national network of 37 blood regions. In addition, the Red Cross supplies one-quarter of the nation's tissue for transplantation through its network of 15 tissue centers nationwide.

(a)This is based on measuring the amount of HAV genomic material present in the product. A negative result means that the product has been tested and shown to have not more than an average of 9.4 GE (genome equivalents) of HAV genomic material per mL.
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Publication:Business Wire
Date:Sep 30, 1999
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