Chiron Corporation received an approval from the US Food and Drug Administration for the Procleix West Nile virus (WNV) assay to screen whole blood donations for use on the Procleix system.

According to a Chiron release, the assay, which was developed in collaboration with Gen-Probe Incorporated, has been used to screen more than 29 million units of blood on an investigational-use-only basis since June of 2003 and intercepted more than 1,500 WNV-positive donations.

"The approval of the Procleix WNV Assay extends Chiron's leadership in the field of blood safety. We are committed to helping our customers safeguard the blood supply against emerging pathogens, such as West Nile virus. We continue to work in collaboration with our customers to meet the urgent need to provide a safe blood supply," said Gene Walther, president, Chiron Blood Testing.

"The safety of the blood supply is a critical concern of the American Red Cross. Being able to screen blood donations for West Nile virus provides an additional layer of safety and reduces the risk of transmission of a potentially deadly virus," said Jack McGuire, executive vice president of American Red Cross Biomedical Services.

West Nile virus is a mosquito-borne virus associated with a human form of the disease ranging from mild, flu-like symptoms to severe neurological disease.

Procleix assays and systems incorporate state-of-the-art NAT technology to detect viral RNA and DNA in donated blood and plasma during the very early stages of infection, when those infectious agents are present but cannot be detected by immunodiagnostic tests.