Novartis has announced that the US Food and Drug Administration (FDA) has cleared the Procleix Tigris System, the first fully automated nucleic acid testing system, to screen donated blood, organs and tissue for the West Nile virus.

Developed by Gen-Probe and marketed by Chiron, a Novartis business, the Procleix Tigris System provides blood centres a fully automated platform for Nucleic Acid Testing (NAT), ensuring rapid delivery of virus-screened blood to hospitals and clinics nationwide. The high-throughput Procleix Tigris System allows blood centres to process 1,000 blood samples in under 14 hours, enabling high volume individual donor testing.

"West Nile virus is a serious threat to the nation's blood supply. With rates of human infection increasing in 2006, reducing the spread of West Nile virus and other infectious diseases is a priority for blood centres nationwide," said Donald Doddridge, president-elect of America's Blood Centres and president of Florida Blood Services. "The ability to combine the Procleix West Nile Virus Assay with the Procleix Tigris System will significantly boost the efficiency of blood centre operations without sacrificing the level of blood safety."

The Procleix Tigris System delivers increased throughput capacity through full automation, including target capture, nucleic acid amplification and detection, in a compact-size instrument. In addition, the system's full automation capabilities allows blood centres to increase blood sample processing during high volume or emergency situations, such as during the peak West Nile virus or mosquito season, without the need for additional resources.

"Our goal is to provide innovative and state-of-the-art technologies to blood centres that will effectively safeguard the nation's blood supply against harmful pathogens and improve blood centre operations," said Gene Walther, president of Chiron and Global Head of Diagnostics. "The clearance of the Procleix Tigris System is a milestone for the industry and, for the first time, allows blood centres a fully automated nucleic acid testing solution to rapidly detect the West Nile virus, a potentially fatal infectious disease."

The Procleix Tigris System has been utilized by select blood centres nationwide to screen for the West Nile virus under an Investigational New Drug (IND) application since August 2004. Since then, millions of units of donated blood have been screened by the system intercepting West Nile virus-positive blood that otherwise may have infected patients with the virus.

The Procleix Tigris System is the first fully automated system for state-of-the art NAT. Developed by Gen-Probe and marketed by Chiron, a Novartis business, the Procleix Tigris System requires minimal operator involvement compared to semi-automated systems.