Blood test granted FDA approval

Chiron Corporation has received US FDA (Food and Drug Administration) approval for the use of its Procleix West Nile Virus (WNV) assay in the screening of 'whole blood donations' for use on the Procleix System.

West Nile Virus is a mosquito-borne virus whose human form can cause anything from mild, flu-like symptoms to severe neurological disease. The first confirmed US death resulting from transmission through donated blood was reported in 2002, and in autumn 2002 the FDA challenged the blood safety industry to develop a test for direct detection of the virus in donated blood by the summer of 2003. Gen-Probe and Chiron therefore developed the Procleix WNV assay and brought it to market on an investigational-use-only basis in June 2003. It has since been used to screen more than 29 million units of blood and intercepted more than 1,500 WNV-positive donations.

Procelix assays and systems incorporate NAT (nucleic acid amplification test) technology to detect viral RNA and DNA in donated blood and plasma during the very early stages of infection, which is when infectious agents are present but cannot be detected by immunodiagnostic tests.

The Procleix HIV-1/HCV assay has been commercially available in Europe since 1999 is also approved for use in the US, Australia and certain markets in Asia. The Procleix Ultrio assay for the simultaneous detection of HIV-1, HCV and HBV has been commercially available in Europe since early 2004.

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